Cobalt Biokinetics, Safety of Cobalt Dietary Supplementation
Conditions
Keywords
Cobalt, Dietary Supplements, Hematological, Thyroid
Brief summary
The purpose of this study is to investigate steady-state cobalt levels following dietary supplementation for 90 days with 1 mg cobalt/day (as cobalt chloride in solution) in healthy adult volunteers.
Detailed description
Over the counter cobalt (Co) dietary supplements are available for sale in the United States, but little is known regarding their clinical effects and biokinetic distribution and body burden with long-term use. This study assessed blood kinetics, steady-state levels, biochemical responses, and clinical effects in five adult males and five adult females who voluntarily ingested approximately 1.0 mg Co/day of a commercially available Co supplement over a three month period. Volunteers were instructed to take the Co-dietary supplement in the morning according to the manufacturer's label. Blood samples were collected and analyzed for a number of biochemical parameters before, during, and after dosing. Hearing, vision, cardiac, and neurological functions were also assessed in volunteers before, during, and after dosing.
Interventions
None listed
Sponsors
DePuy Orthopaedics
Cardno ChemRisk
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject ≥ 18 years old. * Subject able to understand and willing to sign a written informed consent form for the study.
Exclusion criteria
* Subject is unwilling to discontinue current multivitamins or other types of dietary supplements while on study * Subject has a documented history of an allergy to cobalt * Subject has a documented history of severe cardiac problems (e.g., congestive heart failure, myocardial ischemia within past 12 months, cardiomyopathy) * Subject has a documented history of thyroid, kidney, or liver disease * Subject has insulin-dependent diabetes * Subject has a concurrent illness or personal stressor which in the opinion of the investigator may interfere with the subject's ability to perform the study's requirements. * Subject has a total joint replacement (e.g., knee, hip, shoulder) * Subject is pregnant or breastfeeding * Subject is unwilling to follow protocol requirements * Subject weight is less than 45 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cobalt Whole Blood Concentrations | Before, during and after cobalt supplementation | The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing. |
| Cobalt Serum Concentrations | Before, during and after cobalt supplementation | The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Changes in Audiological Function | Baseline, at the study midpoint, and at the study completion | Audiologic assessments including pure tone threshold determination at frequencies ranging from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study (i.e., week 0, \ day 45, \ day 90). Audiologic assessments including a pure-tone threshold determination at frequencies that ranged from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study. Decreases in hearing were considered clinically significant when one of the following 3 American Speech-Language-Hearing Association criteria were met: 1) a ≥20-dB decrease in the pure-tone threshold at one test frequency, 2) a ≥10-dB decrease at 2 adjacent test frequencies, or 3) the loss of 3 consecutive test frequencies where responses were previously obtained. |
| Changes in Cardiac Function | Baseline, at the study midpoint, and at the study completion | Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90). |
| Changes in Visual Function | Baseline, at the study midpoint, and at the study completion | Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90). |
| Changes in Neurological Function (Peroneal Motor Amplitude) | Baseline, at the study midpoint, and at the study completion | Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90, and \ 4-6 post-weeks). |
| White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Hematocrit Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Protein Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Albumin Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| T4 Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Total Iron Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Ferritin Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Creatinine Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Albumin Bound Cobalt Fraction in Serum | Study volunteers will be followed for the duration of the study, an average of about 8 months for most volunteers | The fraction of albumin bound cobalt in serum was determined one to two weeks pre-dosing and on the day of the first dose before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, Day 88/90 and the fraction of albumin bound cobalt in serum was also determined at one and two weeks post-dosing. |
| Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| HDL Cholesterol Levels After 3 Months of Cobalt Supplementation | Study volunteers were assessed before and at the end of cobalt supplementation | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. HDL cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation. |
| Total Cholesterol Levels After 3 Months of Cobalt Supplementation | Study volunteers were assessed before and at the end of cobalt supplementation | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Total cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation. |
| Triglyceride Levels After 3 Months of Cobalt Supplementation | Study volunteers were assessed before and at the end of cobalt supplementation | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Triglyceride levels were assessed before cobalt dietary supplementation and after three months of supplementation. |
| Glucose Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Cobalt Urine Concentrations | During cobalt supplementation | A 24 hr urine collection for cobalt analysis was performed at Day 14/16, Day 43/44 and Day 88/90. |
| Cobalt Urine Concentrations After Cessation of Cobalt Supplementation | After cobalt supplementation | A 24 hr urine collection for cobalt analysis was performed on three volunteers (two females and one male) at one, two, six and ten weeks post-dosing. The one male volunteer provided three consecutive 24-hr urine samples at the one and two week post-dosing time points; data for individual urine collections were averaged together to give an average one and two week post-dosing data concentration. |
| Changes in Cardiac Function (LVEF) | Baseline, at the study midpoint, and at the study completion | Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90). |
| Changes in Cardiac Function (LA Volume Index) | Baseline, at the study midpoint, and at the study completion | Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90). |
| Changes in Visual Function (Average RNFL Thickness) | Baseline, at the study midpoint, and at the study completion | Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90). |
| Changes in Visual Function (Average C:D Ratio) | Baseline, at the study midpoint, and at the study completion | Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90). |
| Changes in Visual Function (Cup Volume) | Baseline, at the study midpoint, and at the study completion | Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90). |
| Changes in Visual Function (VFI) | Baseline, at the study midpoint, and at the study completion | Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90). |
| Changes in Visual Function (Mean Deviation and PSD) | Baseline, at the study midpoint, and at the study completion | Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90). |
| Changes in Neurological Function (Sural Sensory Amplitude) | Baseline, at the study midpoint, and at the study completion | Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90, and \ 4-6 post-weeks). |
| Changes in Neurological Function (Velocity) | Baseline, at the study midpoint, and at the study completion | Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90, and \ 4-6 post-weeks). |
| Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | Study volunteers were assessed before, during and after cobalt supplementation (2 wk post) | Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose. |
| Effects on the Immune System | 0 weeks and three months | Sensitivity to metals before and after cobalt supplementation was assessed by an in vitro lymphocyte transformation test (LTT) performed at week 0 and after three months of cobalt supplementation. The average proliferation rate for each metal treatment was normalized to individual proliferation rates of untreated control cells which generated a stimulation index (SI). According to the manufacture, the SI ranges from 0-15, with an SI from 2 to 4 indicated mild reactivity, from 5 to 8 indicated moderate reactivity, and \>8 indicated high reactivity to the metal. The data is presented as the averaged normalized lymphocyte transformation response to each metal in men and women combined (n = 10). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Volunteers Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\
2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Study Volunteers |
|---|---|
| Age, Continuous Female Age (n=8) | 34 years STANDARD_DEVIATION 10 |
| Age, Continuous Male Age (n=5) | 33 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 5 Participants |
| Weight Female weight (n=5) | 151 pounds (lbs) STANDARD_DEVIATION 20 |
| Weight Male weight (n=5) | 219 pounds (lbs) STANDARD_DEVIATION 53 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Cobalt Serum Concentrations
The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.
Time frame: Before, during and after cobalt supplementation
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Cobalt Serum Concentrations | Day 4/5 | 23.3 µg Co/L | Standard Deviation 12.4 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | Day 8/9 | 42.3 µg Co/L | Standard Deviation 33.4 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | Day 14/16 | 42.5 µg Co/L | Standard Deviation 30.9 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | Day 22/24 | 36.8 µg Co/L | Standard Deviation 24.2 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | Day 29/30 | 53.9 µg Co/L | Standard Deviation 35.8 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | Day 43/44 | 48.2 µg Co/L | Standard Deviation 34.5 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | Day 57/58 | 34.9 µg Co/L | Standard Deviation 20.3 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | Day 71/72 | 46.1 µg Co/L | Standard Deviation 40.8 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | Day 88/90 | 71.2 µg Co/L | Standard Deviation 60 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | 1 wk post | 21.9 µg Co/L | Standard Deviation 20.6 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | 2 wk post | 12.5 µg Co/L | Standard Deviation 11.6 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | 6 wk post | 3.8 µg Co/L | Standard Deviation 3.3 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | 10 wk post | 1.9 µg Co/L | Standard Deviation 1.5 |
| Albumin-Co Fraction | Cobalt Serum Concentrations | 4 month post | 0.96 µg Co/L | Standard Deviation 0.6 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | 2 wk post | 4.6 µg Co/L | Standard Deviation 1.6 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | Day 4/5 | 11.0 µg Co/L | Standard Deviation 5.7 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | Day 71/72 | 28.2 µg Co/L | Standard Deviation 18 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | Day 8/9 | 11.8 µg Co/L | Standard Deviation 9.7 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | 10 wk post | 0.9 µg Co/L | Standard Deviation 0.4 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | Day 14/16 | 20.4 µg Co/L | Standard Deviation 11.5 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | Day 88/90 | 25.2 µg Co/L | Standard Deviation 13.2 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | Day 22/24 | 34.7 µg Co/L | Standard Deviation 23.1 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | 6 wk post | 1.4 µg Co/L | Standard Deviation 0.8 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | Day 29/30 | 23.9 µg Co/L | Standard Deviation 8.7 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | 1 wk post | 8.4 µg Co/L | Standard Deviation 3.1 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | Day 43/44 | 24.3 µg Co/L | Standard Deviation 16.5 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | 4 month post | 0.5 µg Co/L | Standard Deviation 0.3 |
| SI After Cobalt Supplementation | Cobalt Serum Concentrations | Day 57/58 | 24.1 µg Co/L | Standard Deviation 15.7 |
Primary
Cobalt Whole Blood Concentrations
The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.
Time frame: Before, during and after cobalt supplementation
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | Day 4/5 | 14.6 µg Co/L | Standard Deviation 8.2 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | Day 8/9 | 33.9 µg Co/L | Standard Deviation 24 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | Day 14/16 | 29.9 µg Co/L | Standard Deviation 22 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | Day 22/23 | 25.6 µg Co/L | Standard Deviation 17.8 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | Day 29/30 | 37.1 µg Co/L | Standard Deviation 24.8 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | Day 43/44 | 35.9 µg Co/L | Standard Deviation 27.1 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | Day 57/58 | 40.7 µg Co/L | Standard Deviation 28.1 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | Day 71/72 | 37.1 µg Co/L | Standard Deviation 33.7 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | Day 88/90 | 53.3 µg Co/L | Standard Deviation 45.3 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | 1 wk post | 22.2 µg Co/L | Standard Deviation 19.3 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | 2 wk post | 15.9 µg Co/L | Standard Deviation 13.3 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | 6 wk post | 9.7 µg Co/L | Standard Deviation 7.9 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | 10 wk post | 5.9 µg Co/L | Standard Deviation 5.4 |
| Albumin-Co Fraction | Cobalt Whole Blood Concentrations | 16 wk post | 1.1 µg Co/L | Standard Deviation 0.7 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | 2 wk post | 8.7 µg Co/L | Standard Deviation 4.1 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | Day 4/5 | 7.4 µg Co/L | Standard Deviation 3.6 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | Day 71/72 | 22.1 µg Co/L | Standard Deviation 11.5 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | Day 8/9 | 8.5 µg Co/L | Standard Deviation 6.9 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | 10 wk post | 3.9 µg Co/L | Standard Deviation 2.5 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | Day 14/16 | 13.8 µg Co/L | Standard Deviation 6.4 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | Day 88/90 | 20.4 µg Co/L | Standard Deviation 8.5 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | Day 22/23 | 18.7 µg Co/L | Standard Deviation 11.3 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | 6 wk post | 5.6 µg Co/L | Standard Deviation 2.9 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | Day 29/30 | 19.3 µg Co/L | Standard Deviation 7.9 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | 1 wk post | 12.0 µg Co/L | Standard Deviation 6.3 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | Day 43/44 | 18.5 µg Co/L | Standard Deviation 10.5 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | 16 wk post | 0.7 µg Co/L | Standard Deviation 0.2 |
| SI After Cobalt Supplementation | Cobalt Whole Blood Concentrations | Day 57/58 | 20.3 µg Co/L | Standard Deviation 11.1 |
Secondary
Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 14.8 U/L | Standard Deviation 4.19 |
| Albumin-Co Fraction | Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 13.6 U/L | Standard Deviation 4.39 |
| Albumin-Co Fraction | Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 14.8 U/L | Standard Deviation 6.61 |
| Albumin-Co Fraction | Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 11.2 U/L | Standard Deviation 3.11 |
| Albumin-Co Fraction | Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 12.6 U/L | Standard Deviation 3.85 |
| Albumin-Co Fraction | Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 15.8 U/L | Standard Deviation 4.87 |
| SI After Cobalt Supplementation | Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 29.8 U/L | Standard Deviation 15.6 |
| SI After Cobalt Supplementation | Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 30.6 U/L | Standard Deviation 19.3 |
| SI After Cobalt Supplementation | Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 29.4 U/L | Standard Deviation 17.1 |
| SI After Cobalt Supplementation | Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 26.2 U/L | Standard Deviation 13.5 |
| SI After Cobalt Supplementation | Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 29.8 U/L | Standard Deviation 14.5 |
| SI After Cobalt Supplementation | Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 32.0 U/L | Standard Deviation 19.3 |
Secondary
Albumin Bound Cobalt Fraction in Serum
The fraction of albumin bound cobalt in serum was determined one to two weeks pre-dosing and on the day of the first dose before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, Day 88/90 and the fraction of albumin bound cobalt in serum was also determined at one and two weeks post-dosing.
Time frame: Study volunteers will be followed for the duration of the study, an average of about 8 months for most volunteers
Population: Analysis was carried out on the first 12 participants of the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Albumin Bound Cobalt Fraction in Serum | Subject 1 | 94.5 percentage of total blood cobalt | Standard Deviation 4.9 |
| Albumin-Co Fraction | Albumin Bound Cobalt Fraction in Serum | Subject 2 | 95.2 percentage of total blood cobalt | Standard Deviation 3.4 |
| Albumin-Co Fraction | Albumin Bound Cobalt Fraction in Serum | Subject 3 | 96.5 percentage of total blood cobalt | Standard Deviation 2.9 |
| Albumin-Co Fraction | Albumin Bound Cobalt Fraction in Serum | Subject 4 | 93.2 percentage of total blood cobalt | Standard Deviation 2.9 |
| Albumin-Co Fraction | Albumin Bound Cobalt Fraction in Serum | Subject 5 | 96.7 percentage of total blood cobalt | Standard Deviation 2.7 |
| Albumin-Co Fraction | Albumin Bound Cobalt Fraction in Serum | Subject 6 | 95.6 percentage of total blood cobalt | Standard Deviation 4.1 |
| Albumin-Co Fraction | Albumin Bound Cobalt Fraction in Serum | Subject 7 | 95.8 percentage of total blood cobalt | Standard Deviation 2.5 |
| Albumin-Co Fraction | Albumin Bound Cobalt Fraction in Serum | Subject 8 | 95.7 percentage of total blood cobalt | Standard Deviation 2.3 |
| Albumin-Co Fraction | Albumin Bound Cobalt Fraction in Serum | Subject 9 | 98.2 percentage of total blood cobalt | Standard Deviation 2.7 |
| Albumin-Co Fraction | Albumin Bound Cobalt Fraction in Serum | Subject 10 | 94.9 percentage of total blood cobalt | Standard Deviation 3.2 |
| Albumin-Co Fraction | Albumin Bound Cobalt Fraction in Serum | Subject 11 | 95.9 percentage of total blood cobalt | Standard Deviation 2.9 |
| Albumin-Co Fraction | Albumin Bound Cobalt Fraction in Serum | Subject 12 | 96.7 percentage of total blood cobalt | Standard Deviation 1 |
Secondary
Albumin Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Albumin Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 4.39 g/dL | Standard Deviation 0.22 |
| Albumin-Co Fraction | Albumin Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 4.32 g/dL | Standard Deviation 0.16 |
| Albumin-Co Fraction | Albumin Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 4.34 g/dL | Standard Deviation 0.17 |
| Albumin-Co Fraction | Albumin Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 4.28 g/dL | Standard Deviation 0.19 |
| Albumin-Co Fraction | Albumin Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 4.20 g/dL | Standard Deviation 0.27 |
| Albumin-Co Fraction | Albumin Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 4.32 g/dL | Standard Deviation 0.25 |
| SI After Cobalt Supplementation | Albumin Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 4.60 g/dL | Standard Deviation 0.3 |
| SI After Cobalt Supplementation | Albumin Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 4.63 g/dL | Standard Deviation 0.32 |
| SI After Cobalt Supplementation | Albumin Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 4.48 g/dL | Standard Deviation 0.25 |
| SI After Cobalt Supplementation | Albumin Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 4.60 g/dL | Standard Deviation 0.37 |
| SI After Cobalt Supplementation | Albumin Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 4.56 g/dL | Standard Deviation 0.3 |
| SI After Cobalt Supplementation | Albumin Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 4.56 g/dL | Standard Deviation 0.23 |
Secondary
Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 18.8 U/L | Standard Deviation 4.63 |
| Albumin-Co Fraction | Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 17.6 U/L | Standard Deviation 3.51 |
| Albumin-Co Fraction | Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 20.2 U/L | Standard Deviation 8.87 |
| Albumin-Co Fraction | Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 15.8 U/L | Standard Deviation 4.66 |
| Albumin-Co Fraction | Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 16.8 U/L | Standard Deviation 5.36 |
| Albumin-Co Fraction | Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 20.6 U/L | Standard Deviation 6.66 |
| SI After Cobalt Supplementation | Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 23.6 U/L | Standard Deviation 4.72 |
| SI After Cobalt Supplementation | Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 22.9 U/L | Standard Deviation 4.26 |
| SI After Cobalt Supplementation | Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 23.4 U/L | Standard Deviation 6.5 |
| SI After Cobalt Supplementation | Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 21.0 U/L | Standard Deviation 4.06 |
| SI After Cobalt Supplementation | Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 25.8 U/L | Standard Deviation 9.6 |
| SI After Cobalt Supplementation | Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 22.4 U/L | Standard Deviation 7.02 |
Secondary
Changes in Audiological Function
Audiologic assessments including pure tone threshold determination at frequencies ranging from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study (i.e., week 0, \ day 45, \ day 90). Audiologic assessments including a pure-tone threshold determination at frequencies that ranged from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study. Decreases in hearing were considered clinically significant when one of the following 3 American Speech-Language-Hearing Association criteria were met: 1) a ≥20-dB decrease in the pure-tone threshold at one test frequency, 2) a ≥10-dB decrease at 2 adjacent test frequencies, or 3) the loss of 3 consecutive test frequencies where responses were previously obtained.
Time frame: Baseline, at the study midpoint, and at the study completion
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Changes in Audiological Function | 4000 Hz | 10.5 dB | Standard Deviation 9 |
| Albumin-Co Fraction | Changes in Audiological Function | 2000 Hz | 9.0 dB | Standard Deviation 5.7 |
| Albumin-Co Fraction | Changes in Audiological Function | 1000 Hz | 9.0 dB | Standard Deviation 3.2 |
| Albumin-Co Fraction | Changes in Audiological Function | 16,000 Hz | 24.0 dB | Standard Deviation 21.2 |
| Albumin-Co Fraction | Changes in Audiological Function | 12,000 Hz | 9.5 dB | Standard Deviation 13 |
| Albumin-Co Fraction | Changes in Audiological Function | 8000 Hz | 5.5 dB | Standard Deviation 7.6 |
| Albumin-Co Fraction | Changes in Audiological Function | 3000 Hz | 7.0 dB | Standard Deviation 7.5 |
| Albumin-Co Fraction | Changes in Audiological Function | 500 Hz | 10.0 dB | Standard Deviation 4.1 |
| Albumin-Co Fraction | Changes in Audiological Function | 250 Hz | 10.0 dB | Standard Deviation 4.7 |
| Albumin-Co Fraction | Changes in Audiological Function | 6000 Hz | 10.0 dB | Standard Deviation 8.5 |
| SI After Cobalt Supplementation | Changes in Audiological Function | 6000 Hz | 12.0 dB | Standard Deviation 8.9 |
| SI After Cobalt Supplementation | Changes in Audiological Function | 250 Hz | 8.0 dB | Standard Deviation 6.3 |
| SI After Cobalt Supplementation | Changes in Audiological Function | 500 Hz | 6.0 dB | Standard Deviation 6.1 |
| SI After Cobalt Supplementation | Changes in Audiological Function | 1000 Hz | 7.5 dB | Standard Deviation 2.6 |
| SI After Cobalt Supplementation | Changes in Audiological Function | 2000 Hz | 9.5 dB | Standard Deviation 4.4 |
| SI After Cobalt Supplementation | Changes in Audiological Function | 3000 Hz | 8.5 dB | Standard Deviation 4.7 |
| SI After Cobalt Supplementation | Changes in Audiological Function | 4000 Hz | 6.0 dB | Standard Deviation 5.7 |
| SI After Cobalt Supplementation | Changes in Audiological Function | 8000 Hz | 10.0 dB | Standard Deviation 7.8 |
| SI After Cobalt Supplementation | Changes in Audiological Function | 12,000 Hz | 7.5 dB | Standard Deviation 10.1 |
| SI After Cobalt Supplementation | Changes in Audiological Function | 16,000 Hz | 25.5 dB | Standard Deviation 24.9 |
| Study Midpoint - Left | Changes in Audiological Function | 8000 Hz | 8.5 dB | Standard Deviation 8.8 |
| Study Midpoint - Left | Changes in Audiological Function | 16,000 Hz | 21.0 dB | Standard Deviation 22.6 |
| Study Midpoint - Left | Changes in Audiological Function | 4000 Hz | 9.5 dB | Standard Deviation 10.1 |
| Study Midpoint - Left | Changes in Audiological Function | 3000 Hz | 7.5 dB | Standard Deviation 6.8 |
| Study Midpoint - Left | Changes in Audiological Function | 2000 Hz | 8.5 dB | Standard Deviation 6.7 |
| Study Midpoint - Left | Changes in Audiological Function | 1000 Hz | 6.5 dB | Standard Deviation 4.1 |
| Study Midpoint - Left | Changes in Audiological Function | 500 Hz | 8.5 dB | Standard Deviation 4.7 |
| Study Midpoint - Left | Changes in Audiological Function | 12,000 Hz | 8.5 dB | Standard Deviation 11.8 |
| Study Midpoint - Left | Changes in Audiological Function | 6000 Hz | 11.0 dB | Standard Deviation 9.1 |
| Study Midpoint - Left | Changes in Audiological Function | 250 Hz | 9.0 dB | Standard Deviation 3.9 |
| Study Midpoint - Right | Changes in Audiological Function | 6000 Hz | 11.0 dB | Standard Deviation 9.9 |
| Study Midpoint - Right | Changes in Audiological Function | 250 Hz | 8.0 dB | Standard Deviation 6.7 |
| Study Midpoint - Right | Changes in Audiological Function | 1000 Hz | 5.0 dB | Standard Deviation 4.1 |
| Study Midpoint - Right | Changes in Audiological Function | 16,000 Hz | 25.0 dB | Standard Deviation 24.7 |
| Study Midpoint - Right | Changes in Audiological Function | 8000 Hz | 7.5 dB | Standard Deviation 7.2 |
| Study Midpoint - Right | Changes in Audiological Function | 3000 Hz | 8.0 dB | Standard Deviation 4.2 |
| Study Midpoint - Right | Changes in Audiological Function | 2000 Hz | 9.5 dB | Standard Deviation 6 |
| Study Midpoint - Right | Changes in Audiological Function | 500 Hz | 7.5 dB | Standard Deviation 6.8 |
| Study Midpoint - Right | Changes in Audiological Function | 4000 Hz | 6.0 dB | Standard Deviation 5.2 |
| Study Midpoint - Right | Changes in Audiological Function | 12,000 Hz | 9.0 dB | Standard Deviation 8.1 |
| Study Completion - Left | Changes in Audiological Function | 500 Hz | 6.5 dB | Standard Deviation 4.7 |
| Study Completion - Left | Changes in Audiological Function | 2000 Hz | 7.0 dB | Standard Deviation 6.8 |
| Study Completion - Left | Changes in Audiological Function | 3000 Hz | 8.0 dB | Standard Deviation 7.5 |
| Study Completion - Left | Changes in Audiological Function | 4000 Hz | 8.5 dB | Standard Deviation 10.5 |
| Study Completion - Left | Changes in Audiological Function | 6000 Hz | 9.0 dB | Standard Deviation 6.9 |
| Study Completion - Left | Changes in Audiological Function | 250 Hz | 7.5 dB | Standard Deviation 3.5 |
| Study Completion - Left | Changes in Audiological Function | 8000 Hz | 9.0 dB | Standard Deviation 7.1 |
| Study Completion - Left | Changes in Audiological Function | 16,000 Hz | 22.0 dB | Standard Deviation 20 |
| Study Completion - Left | Changes in Audiological Function | 12,000 Hz | 9.5 dB | Standard Deviation 12.4 |
| Study Completion - Left | Changes in Audiological Function | 1000 Hz | 6.5 dB | Standard Deviation 4.7 |
| Study Completion - Right | Changes in Audiological Function | 250 Hz | 6.0 dB | Standard Deviation 5.7 |
| Study Completion - Right | Changes in Audiological Function | 4000 Hz | 7.5 dB | Standard Deviation 5.4 |
| Study Completion - Right | Changes in Audiological Function | 1000 Hz | 7.5 dB | Standard Deviation 4.2 |
| Study Completion - Right | Changes in Audiological Function | 500 Hz | 5.5 dB | Standard Deviation 5 |
| Study Completion - Right | Changes in Audiological Function | 12,000 Hz | 8.0 dB | Standard Deviation 7.9 |
| Study Completion - Right | Changes in Audiological Function | 3000 Hz | 5.0 dB | Standard Deviation 3.3 |
| Study Completion - Right | Changes in Audiological Function | 16,000 Hz | 24.0 dB | Standard Deviation 22.2 |
| Study Completion - Right | Changes in Audiological Function | 8000 Hz | 7.5 dB | Standard Deviation 5.4 |
| Study Completion - Right | Changes in Audiological Function | 6000 Hz | 10.0 dB | Standard Deviation 9.7 |
| Study Completion - Right | Changes in Audiological Function | 2000 Hz | 7.5 dB | Standard Deviation 6.3 |
Secondary
Changes in Cardiac Function
Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90).
Time frame: Baseline, at the study midpoint, and at the study completion
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Changes in Cardiac Function | Ao Root (ed) (cm) | 2.99 cm | Standard Deviation 0.38 |
| Albumin-Co Fraction | Changes in Cardiac Function | LA (es) (cm) | 3.15 cm | Standard Deviation 0.21 |
| Albumin-Co Fraction | Changes in Cardiac Function | IVS (es) (cm) | 1.40 cm | Standard Deviation 0.24 |
| Albumin-Co Fraction | Changes in Cardiac Function | IVS (ed) (cm) | 1.07 cm | Standard Deviation 0.19 |
| Albumin-Co Fraction | Changes in Cardiac Function | LVID (ed) (cm) | 4.77 cm | Standard Deviation 0.52 |
| Albumin-Co Fraction | Changes in Cardiac Function | LVPWs (es) (cm) | 1.49 cm | Standard Deviation 0.19 |
| Albumin-Co Fraction | Changes in Cardiac Function | RVID (ed) (cm) | 2.08 cm | Standard Deviation 0.46 |
| Albumin-Co Fraction | Changes in Cardiac Function | LVID (es) (cm) | 3.15 cm | Standard Deviation 0.38 |
| Albumin-Co Fraction | Changes in Cardiac Function | LVPWs (ed) (cm) | 0.94 cm | Standard Deviation 0.12 |
| SI After Cobalt Supplementation | Changes in Cardiac Function | IVS (ed) (cm) | 1.06 cm | Standard Deviation 0.22 |
| SI After Cobalt Supplementation | Changes in Cardiac Function | LVID (ed) (cm) | 4.75 cm | Standard Deviation 0.55 |
| SI After Cobalt Supplementation | Changes in Cardiac Function | LVID (es) (cm) | 2.97 cm | Standard Deviation 0.49 |
| SI After Cobalt Supplementation | Changes in Cardiac Function | RVID (ed) (cm) | 2.02 cm | Standard Deviation 0.38 |
| SI After Cobalt Supplementation | Changes in Cardiac Function | Ao Root (ed) (cm) | 3.03 cm | Standard Deviation 0.45 |
| SI After Cobalt Supplementation | Changes in Cardiac Function | IVS (es) (cm) | 1.46 cm | Standard Deviation 0.24 |
| SI After Cobalt Supplementation | Changes in Cardiac Function | LVPWs (ed) (cm) | 0.95 cm | Standard Deviation 0.11 |
| SI After Cobalt Supplementation | Changes in Cardiac Function | LVPWs (es) (cm) | 1.47 cm | Standard Deviation 0.18 |
| SI After Cobalt Supplementation | Changes in Cardiac Function | LA (es) (cm) | 3.34 cm | Standard Deviation 0.34 |
| Study Midpoint - Left | Changes in Cardiac Function | RVID (ed) (cm) | 2.16 cm | Standard Deviation 0.35 |
| Study Midpoint - Left | Changes in Cardiac Function | LVID (ed) (cm) | 4.65 cm | Standard Deviation 0.44 |
| Study Midpoint - Left | Changes in Cardiac Function | LVPWs (ed) (cm) | 0.99 cm | Standard Deviation 0.13 |
| Study Midpoint - Left | Changes in Cardiac Function | LVID (es) (cm) | 2.95 cm | Standard Deviation 0.55 |
| Study Midpoint - Left | Changes in Cardiac Function | LA (es) (cm) | 3.13 cm | Standard Deviation 0.44 |
| Study Midpoint - Left | Changes in Cardiac Function | IVS (ed) (cm) | 1.05 cm | Standard Deviation 0.13 |
| Study Midpoint - Left | Changes in Cardiac Function | Ao Root (ed) (cm) | 3.01 cm | Standard Deviation 0.44 |
| Study Midpoint - Left | Changes in Cardiac Function | LVPWs (es) (cm) | 1.52 cm | Standard Deviation 0.15 |
| Study Midpoint - Left | Changes in Cardiac Function | IVS (es) (cm) | 1.48 cm | Standard Deviation 0.24 |
Secondary
Changes in Cardiac Function (LA Volume Index)
Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90).
Time frame: Baseline, at the study midpoint, and at the study completion
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albumin-Co Fraction | Changes in Cardiac Function (LA Volume Index) | 23.3 LA volume index (mL/m^2) | Standard Deviation 4.27 |
| SI After Cobalt Supplementation | Changes in Cardiac Function (LA Volume Index) | 24.2 LA volume index (mL/m^2) | Standard Deviation 5.33 |
| Study Midpoint - Left | Changes in Cardiac Function (LA Volume Index) | 24.0 LA volume index (mL/m^2) | Standard Deviation 6.08 |
Secondary
Changes in Cardiac Function (LVEF)
Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90).
Time frame: Baseline, at the study midpoint, and at the study completion
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albumin-Co Fraction | Changes in Cardiac Function (LVEF) | 65.9 LVEF (2D est) (%) | Standard Deviation 4.43 |
| SI After Cobalt Supplementation | Changes in Cardiac Function (LVEF) | 66.8 LVEF (2D est) (%) | Standard Deviation 4.21 |
| Study Midpoint - Left | Changes in Cardiac Function (LVEF) | 65.0 LVEF (2D est) (%) | Standard Deviation 2.54 |
Secondary
Changes in Neurological Function (Peroneal Motor Amplitude)
Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90, and \ 4-6 post-weeks).
Time frame: Baseline, at the study midpoint, and at the study completion
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albumin-Co Fraction | Changes in Neurological Function (Peroneal Motor Amplitude) | 5.1 Peroneal Motor Amplitude (mV) | Standard Deviation 2.3 |
| SI After Cobalt Supplementation | Changes in Neurological Function (Peroneal Motor Amplitude) | 5.5 Peroneal Motor Amplitude (mV) | Standard Deviation 2.3 |
| Study Midpoint - Left | Changes in Neurological Function (Peroneal Motor Amplitude) | 5.6 Peroneal Motor Amplitude (mV) | Standard Deviation 3 |
Secondary
Changes in Neurological Function (Sural Sensory Amplitude)
Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90, and \ 4-6 post-weeks).
Time frame: Baseline, at the study midpoint, and at the study completion
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albumin-Co Fraction | Changes in Neurological Function (Sural Sensory Amplitude) | 24.2 Sural Sensory Amplitude (µV) | Standard Deviation 14.8 |
| SI After Cobalt Supplementation | Changes in Neurological Function (Sural Sensory Amplitude) | 23.4 Sural Sensory Amplitude (µV) | Standard Deviation 14.9 |
| Study Midpoint - Left | Changes in Neurological Function (Sural Sensory Amplitude) | 20.7 Sural Sensory Amplitude (µV) | Standard Deviation 12.4 |
| Study Midpoint - Right | Changes in Neurological Function (Sural Sensory Amplitude) | 28.3 Sural Sensory Amplitude (µV) | Standard Deviation 24.2 |
Secondary
Changes in Neurological Function (Velocity)
Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90, and \ 4-6 post-weeks).
Time frame: Baseline, at the study midpoint, and at the study completion
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Changes in Neurological Function (Velocity) | Peroneal Motor Velocity | 58.7 m/s | Standard Deviation 13.7 |
| Albumin-Co Fraction | Changes in Neurological Function (Velocity) | Sural Sensory Velocity | 42.4 m/s | Standard Deviation 5.8 |
| SI After Cobalt Supplementation | Changes in Neurological Function (Velocity) | Sural Sensory Velocity | 39.9 m/s | Standard Deviation 7.4 |
| SI After Cobalt Supplementation | Changes in Neurological Function (Velocity) | Peroneal Motor Velocity | 64.1 m/s | Standard Deviation 18.7 |
| Study Midpoint - Left | Changes in Neurological Function (Velocity) | Peroneal Motor Velocity | 63.2 m/s | Standard Deviation 24.8 |
| Study Midpoint - Left | Changes in Neurological Function (Velocity) | Sural Sensory Velocity | 36.4 m/s | Standard Deviation 7 |
| Study Midpoint - Right | Changes in Neurological Function (Velocity) | Peroneal Motor Velocity | 0 m/s | Standard Deviation 0 |
| Study Midpoint - Right | Changes in Neurological Function (Velocity) | Sural Sensory Velocity | 43.3 m/s | Standard Deviation 7.8 |
Secondary
Changes in Visual Function
Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90).
Time frame: Baseline, at the study midpoint, and at the study completion
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Changes in Visual Function | Rim area (mm^2) | 1.29 mm^2 | Standard Deviation 0.23 |
| Albumin-Co Fraction | Changes in Visual Function | Disc Area (mm^2) | 1.65 mm^2 | Standard Deviation 0.3 |
| SI After Cobalt Supplementation | Changes in Visual Function | Rim area (mm^2) | 1.35 mm^2 | Standard Deviation 0.23 |
| SI After Cobalt Supplementation | Changes in Visual Function | Disc Area (mm^2) | 1.73 mm^2 | Standard Deviation 0.31 |
| Study Midpoint - Left | Changes in Visual Function | Rim area (mm^2) | 1.38 mm^2 | Standard Deviation 0.23 |
| Study Midpoint - Left | Changes in Visual Function | Disc Area (mm^2) | 1.71 mm^2 | Standard Deviation 0.33 |
| Study Midpoint - Right | Changes in Visual Function | Rim area (mm^2) | 1.39 mm^2 | Standard Deviation 0.29 |
| Study Midpoint - Right | Changes in Visual Function | Disc Area (mm^2) | 1.74 mm^2 | Standard Deviation 0.42 |
| Study Completion - Left | Changes in Visual Function | Rim area (mm^2) | 1.31 mm^2 | Standard Deviation 0.19 |
| Study Completion - Left | Changes in Visual Function | Disc Area (mm^2) | 1.59 mm^2 | Standard Deviation 0.2 |
| Study Completion - Right | Changes in Visual Function | Rim area (mm^2) | 1.36 mm^2 | Standard Deviation 0.25 |
| Study Completion - Right | Changes in Visual Function | Disc Area (mm^2) | 1.63 mm^2 | Standard Deviation 0.27 |
Secondary
Changes in Visual Function (Average C:D Ratio)
Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90).
Time frame: Baseline, at the study midpoint, and at the study completion
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Changes in Visual Function (Average C:D Ratio) | Average C:D ratio | 0.43 ratio | Standard Deviation 0.12 |
| Albumin-Co Fraction | Changes in Visual Function (Average C:D Ratio) | Vertical C:D ratio | 0.41 ratio | Standard Deviation 0.13 |
| SI After Cobalt Supplementation | Changes in Visual Function (Average C:D Ratio) | Average C:D ratio | 0.44 ratio | Standard Deviation 0.11 |
| SI After Cobalt Supplementation | Changes in Visual Function (Average C:D Ratio) | Vertical C:D ratio | 0.40 ratio | Standard Deviation 0.1 |
| Study Midpoint - Left | Changes in Visual Function (Average C:D Ratio) | Average C:D ratio | 0.41 ratio | Standard Deviation 0.13 |
| Study Midpoint - Left | Changes in Visual Function (Average C:D Ratio) | Vertical C:D ratio | 0.40 ratio | Standard Deviation 0.12 |
| Study Midpoint - Right | Changes in Visual Function (Average C:D Ratio) | Average C:D ratio | 0.42 ratio | Standard Deviation 0.12 |
| Study Midpoint - Right | Changes in Visual Function (Average C:D Ratio) | Vertical C:D ratio | 0.39 ratio | Standard Deviation 0.11 |
| Study Completion - Left | Changes in Visual Function (Average C:D Ratio) | Average C:D ratio | 0.40 ratio | Standard Deviation 0.12 |
| Study Completion - Left | Changes in Visual Function (Average C:D Ratio) | Vertical C:D ratio | 0.38 ratio | Standard Deviation 0.13 |
| Study Completion - Right | Changes in Visual Function (Average C:D Ratio) | Average C:D ratio | 0.40 ratio | Standard Deviation 0.11 |
| Study Completion - Right | Changes in Visual Function (Average C:D Ratio) | Vertical C:D ratio | 0.36 ratio | Standard Deviation 0.1 |
Secondary
Changes in Visual Function (Average RNFL Thickness)
Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90).
Time frame: Baseline, at the study midpoint, and at the study completion
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albumin-Co Fraction | Changes in Visual Function (Average RNFL Thickness) | 97.10 Average RNFL thickness (µm) | Standard Deviation 7.89 |
| SI After Cobalt Supplementation | Changes in Visual Function (Average RNFL Thickness) | 97.00 Average RNFL thickness (µm) | Standard Deviation 8.67 |
| Study Midpoint - Left | Changes in Visual Function (Average RNFL Thickness) | 97.00 Average RNFL thickness (µm) | Standard Deviation 7.89 |
| Study Midpoint - Right | Changes in Visual Function (Average RNFL Thickness) | 96.30 Average RNFL thickness (µm) | Standard Deviation 8.64 |
| Study Completion - Left | Changes in Visual Function (Average RNFL Thickness) | 96.50 Average RNFL thickness (µm) | Standard Deviation 7.81 |
| Study Completion - Right | Changes in Visual Function (Average RNFL Thickness) | 96.50 Average RNFL thickness (µm) | Standard Deviation 9.01 |
Secondary
Changes in Visual Function (Cup Volume)
Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90).
Time frame: Baseline, at the study midpoint, and at the study completion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albumin-Co Fraction | Changes in Visual Function (Cup Volume) | 0.09 mm^3 | Standard Deviation 0.06 |
| SI After Cobalt Supplementation | Changes in Visual Function (Cup Volume) | 0.08 mm^3 | Standard Deviation 0.04 |
| Study Midpoint - Left | Changes in Visual Function (Cup Volume) | 0.08 mm^3 | Standard Deviation 0.05 |
| Study Midpoint - Right | Changes in Visual Function (Cup Volume) | 0.07 mm^3 | Standard Deviation 0.04 |
| Study Completion - Left | Changes in Visual Function (Cup Volume) | 0.08 mm^3 | Standard Deviation 0.05 |
| Study Completion - Right | Changes in Visual Function (Cup Volume) | 0.07 mm^3 | Standard Deviation 0.04 |
Secondary
Changes in Visual Function (Mean Deviation and PSD)
Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90).
Time frame: Baseline, at the study midpoint, and at the study completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Changes in Visual Function (Mean Deviation and PSD) | Mean deviation (dB) | -0.22 dB | Standard Deviation 1.01 |
| Albumin-Co Fraction | Changes in Visual Function (Mean Deviation and PSD) | PSD (dB) | 1.44 dB | Standard Deviation 0.31 |
| SI After Cobalt Supplementation | Changes in Visual Function (Mean Deviation and PSD) | Mean deviation (dB) | -0.25 dB | Standard Deviation 0.78 |
| SI After Cobalt Supplementation | Changes in Visual Function (Mean Deviation and PSD) | PSD (dB) | 1.38 dB | Standard Deviation 0.3 |
| Study Midpoint - Left | Changes in Visual Function (Mean Deviation and PSD) | Mean deviation (dB) | 0.29 dB | Standard Deviation 0.85 |
| Study Midpoint - Left | Changes in Visual Function (Mean Deviation and PSD) | PSD (dB) | 1.37 dB | Standard Deviation 0.3 |
| Study Midpoint - Right | Changes in Visual Function (Mean Deviation and PSD) | Mean deviation (dB) | 0.02 dB | Standard Deviation 0.69 |
| Study Midpoint - Right | Changes in Visual Function (Mean Deviation and PSD) | PSD (dB) | 1.28 dB | Standard Deviation 0.13 |
| Study Completion - Left | Changes in Visual Function (Mean Deviation and PSD) | Mean deviation (dB) | 0.26 dB | Standard Deviation 0.82 |
| Study Completion - Left | Changes in Visual Function (Mean Deviation and PSD) | PSD (dB) | 1.26 dB | Standard Deviation 0.16 |
| Study Completion - Right | Changes in Visual Function (Mean Deviation and PSD) | Mean deviation (dB) | -0.09 dB | Standard Deviation 0.89 |
| Study Completion - Right | Changes in Visual Function (Mean Deviation and PSD) | PSD (dB) | 1.26 dB | Standard Deviation 0.16 |
Secondary
Changes in Visual Function (VFI)
Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \ day 45, \ day 90).
Time frame: Baseline, at the study midpoint, and at the study completion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albumin-Co Fraction | Changes in Visual Function (VFI) | 99.40 VFI (%) | Standard Deviation 0.7 |
| SI After Cobalt Supplementation | Changes in Visual Function (VFI) | 99.30 VFI (%) | Standard Deviation 0.82 |
| Study Midpoint - Left | Changes in Visual Function (VFI) | 99.30 VFI (%) | Standard Deviation 0.48 |
| Study Midpoint - Right | Changes in Visual Function (VFI) | 99.50 VFI (%) | Standard Deviation 0.97 |
| Study Completion - Left | Changes in Visual Function (VFI) | 99.60 VFI (%) | Standard Deviation 0.52 |
| Study Completion - Right | Changes in Visual Function (VFI) | 99.70 VFI (%) | Standard Deviation 0.48 |
Secondary
Cobalt Urine Concentrations
A 24 hr urine collection for cobalt analysis was performed at Day 14/16, Day 43/44 and Day 88/90.
Time frame: During cobalt supplementation
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Cobalt Urine Concentrations | Day 14/16 | 186 µg/L | Standard Deviation 170 |
| Albumin-Co Fraction | Cobalt Urine Concentrations | Day 43/44 | 226 µg/L | Standard Deviation 228 |
| Albumin-Co Fraction | Cobalt Urine Concentrations | Day 88/90 | 193 µg/L | Standard Deviation 179 |
| SI After Cobalt Supplementation | Cobalt Urine Concentrations | Day 14/16 | 119 µg/L | Standard Deviation 114 |
| SI After Cobalt Supplementation | Cobalt Urine Concentrations | Day 88/90 | 70 µg/L | Standard Deviation 29 |
| SI After Cobalt Supplementation | Cobalt Urine Concentrations | Day 43/44 | 46 µg/L | Standard Deviation 35 |
Secondary
Cobalt Urine Concentrations After Cessation of Cobalt Supplementation
A 24 hr urine collection for cobalt analysis was performed on three volunteers (two females and one male) at one, two, six and ten weeks post-dosing. The one male volunteer provided three consecutive 24-hr urine samples at the one and two week post-dosing time points; data for individual urine collections were averaged together to give an average one and two week post-dosing data concentration.
Time frame: After cobalt supplementation
Population: Participants that completed three months of cobalt supplementation and volunteered to do additional urine collections after stopping cobalt supplementation. n represents the number of urine samples analyzd at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Cobalt Urine Concentrations After Cessation of Cobalt Supplementation | 1 wk postdose (n = 5, 3) | 38 µg/L | Standard Deviation 29 |
| Albumin-Co Fraction | Cobalt Urine Concentrations After Cessation of Cobalt Supplementation | 2 wk postdose (n = 4, 3) | 19 µg/L | Standard Deviation 18 |
| Albumin-Co Fraction | Cobalt Urine Concentrations After Cessation of Cobalt Supplementation | 6 wk postdose (n = 2, 1) | 6 µg/L | Standard Deviation 5 |
| Albumin-Co Fraction | Cobalt Urine Concentrations After Cessation of Cobalt Supplementation | 10 wk postdose (n = 2, 1) | 6 µg/L | Standard Deviation 7 |
| SI After Cobalt Supplementation | Cobalt Urine Concentrations After Cessation of Cobalt Supplementation | 10 wk postdose (n = 2, 1) | 1 µg/L | Standard Deviation 0 |
| SI After Cobalt Supplementation | Cobalt Urine Concentrations After Cessation of Cobalt Supplementation | 1 wk postdose (n = 5, 3) | 14 µg/L | Standard Deviation 6 |
| SI After Cobalt Supplementation | Cobalt Urine Concentrations After Cessation of Cobalt Supplementation | 6 wk postdose (n = 2, 1) | 2 µg/L | Standard Deviation 0 |
| SI After Cobalt Supplementation | Cobalt Urine Concentrations After Cessation of Cobalt Supplementation | 2 wk postdose (n = 4, 3) | 7 µg/L | Standard Deviation 2 |
Secondary
Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 0.61 ng/mL | Standard Deviation 0.37 |
| Albumin-Co Fraction | Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 0.80 ng/mL | Standard Deviation 0.45 |
| Albumin-Co Fraction | Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 0.59 ng/mL | Standard Deviation 0.35 |
| Albumin-Co Fraction | Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 1.03 ng/mL | Standard Deviation 0.56 |
| Albumin-Co Fraction | Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 0.81 ng/mL | Standard Deviation 0.36 |
| Albumin-Co Fraction | Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 1.09 ng/mL | Standard Deviation 0.48 |
| SI After Cobalt Supplementation | Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 1.25 ng/mL | Standard Deviation 1.08 |
| SI After Cobalt Supplementation | Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 1.58 ng/mL | Standard Deviation 0.68 |
| SI After Cobalt Supplementation | Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 1.23 ng/mL | Standard Deviation 0.82 |
| SI After Cobalt Supplementation | Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 0.97 ng/mL | Standard Deviation 0.95 |
| SI After Cobalt Supplementation | Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 1.42 ng/mL | Standard Deviation 1.53 |
| SI After Cobalt Supplementation | Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 0.92 ng/mL | Standard Deviation 0.85 |
Secondary
Creatinine Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Creatinine Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 0.79 mg/dL | Standard Deviation 0.09 |
| Albumin-Co Fraction | Creatinine Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 0.78 mg/dL | Standard Deviation 0.07 |
| Albumin-Co Fraction | Creatinine Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 0.77 mg/dL | Standard Deviation 0.08 |
| Albumin-Co Fraction | Creatinine Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 0.80 mg/dL | Standard Deviation 0.06 |
| Albumin-Co Fraction | Creatinine Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 0.84 mg/dL | Standard Deviation 0.09 |
| Albumin-Co Fraction | Creatinine Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 0.82 mg/dL | Standard Deviation 0.13 |
| SI After Cobalt Supplementation | Creatinine Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 1.02 mg/dL | Standard Deviation 0.12 |
| SI After Cobalt Supplementation | Creatinine Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 1.05 mg/dL | Standard Deviation 0.09 |
| SI After Cobalt Supplementation | Creatinine Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 0.99 mg/dL | Standard Deviation 0.1 |
| SI After Cobalt Supplementation | Creatinine Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 1.01 mg/dL | Standard Deviation 0.16 |
| SI After Cobalt Supplementation | Creatinine Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 1.05 mg/dL | Standard Deviation 0.1 |
| SI After Cobalt Supplementation | Creatinine Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 1.04 mg/dL | Standard Deviation 0.11 |
Secondary
Effects on the Immune System
Sensitivity to metals before and after cobalt supplementation was assessed by an in vitro lymphocyte transformation test (LTT) performed at week 0 and after three months of cobalt supplementation. The average proliferation rate for each metal treatment was normalized to individual proliferation rates of untreated control cells which generated a stimulation index (SI). According to the manufacture, the SI ranges from 0-15, with an SI from 2 to 4 indicated mild reactivity, from 5 to 8 indicated moderate reactivity, and \>8 indicated high reactivity to the metal. The data is presented as the averaged normalized lymphocyte transformation response to each metal in men and women combined (n = 10).
Time frame: 0 weeks and three months
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Effects on the Immune System | Normalized lymphocyte transformation response: Al | 1.79 units on a scale: stimulation index (SI) | Standard Deviation 1.77 |
| Albumin-Co Fraction | Effects on the Immune System | Normalized lymphocyte transformation response: Co | 1.05 units on a scale: stimulation index (SI) | Standard Deviation 0.32 |
| Albumin-Co Fraction | Effects on the Immune System | Normalized lymphocyte transformation response: Cr | 1.01 units on a scale: stimulation index (SI) | Standard Deviation 0.38 |
| Albumin-Co Fraction | Effects on the Immune System | Normalized lymphocyte transformation response: Mo | 1.23 units on a scale: stimulation index (SI) | Standard Deviation 1.21 |
| Albumin-Co Fraction | Effects on the Immune System | Normalized lymphocyte transformation response: Ni | 4.21 units on a scale: stimulation index (SI) | Standard Deviation 3.62 |
| Albumin-Co Fraction | Effects on the Immune System | Normalized lymphocyte transformation response: V | 1.63 units on a scale: stimulation index (SI) | Standard Deviation 0.82 |
| Albumin-Co Fraction | Effects on the Immune System | Normalized lymphocyte transformation response: Zr | 1.43 units on a scale: stimulation index (SI) | Standard Deviation 0.56 |
| Albumin-Co Fraction | Effects on the Immune System | Normalized lymphocyte transformation response: Fe | 1.47 units on a scale: stimulation index (SI) | Standard Deviation 0.91 |
| SI After Cobalt Supplementation | Effects on the Immune System | Normalized lymphocyte transformation response: Fe | 1.82 units on a scale: stimulation index (SI) | Standard Deviation 1.62 |
| SI After Cobalt Supplementation | Effects on the Immune System | Normalized lymphocyte transformation response: Al | 2.34 units on a scale: stimulation index (SI) | Standard Deviation 3 |
| SI After Cobalt Supplementation | Effects on the Immune System | Normalized lymphocyte transformation response: Ni | 4.32 units on a scale: stimulation index (SI) | Standard Deviation 3 |
| SI After Cobalt Supplementation | Effects on the Immune System | Normalized lymphocyte transformation response: Co | 1.44 units on a scale: stimulation index (SI) | Standard Deviation 0.72 |
| SI After Cobalt Supplementation | Effects on the Immune System | Normalized lymphocyte transformation response: Zr | 1.41 units on a scale: stimulation index (SI) | Standard Deviation 0.87 |
| SI After Cobalt Supplementation | Effects on the Immune System | Normalized lymphocyte transformation response: Cr | 1.43 units on a scale: stimulation index (SI) | Standard Deviation 0.46 |
| SI After Cobalt Supplementation | Effects on the Immune System | Normalized lymphocyte transformation response: V | 1.86 units on a scale: stimulation index (SI) | Standard Deviation 0.79 |
| SI After Cobalt Supplementation | Effects on the Immune System | Normalized lymphocyte transformation response: Mo | 2.31 units on a scale: stimulation index (SI) | Standard Deviation 1.17 |
Secondary
Ferritin Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Ferritin Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 51.3 ng/mL | Standard Deviation 40.4 |
| Albumin-Co Fraction | Ferritin Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 32.0 ng/mL | Standard Deviation 24.2 |
| Albumin-Co Fraction | Ferritin Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 27.4 ng/mL | Standard Deviation 23.2 |
| Albumin-Co Fraction | Ferritin Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 21.6 ng/mL | Standard Deviation 14.7 |
| Albumin-Co Fraction | Ferritin Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 34.6 ng/mL | Standard Deviation 43.4 |
| Albumin-Co Fraction | Ferritin Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 24.8 ng/mL | Standard Deviation 18.7 |
| SI After Cobalt Supplementation | Ferritin Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 74.6 ng/mL | Standard Deviation 50.3 |
| SI After Cobalt Supplementation | Ferritin Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 136 ng/mL | Standard Deviation 77.3 |
| SI After Cobalt Supplementation | Ferritin Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 85.2 ng/mL | Standard Deviation 53.1 |
| SI After Cobalt Supplementation | Ferritin Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 95.2 ng/mL | Standard Deviation 57.5 |
| SI After Cobalt Supplementation | Ferritin Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 90.4 ng/mL | Standard Deviation 66 |
| SI After Cobalt Supplementation | Ferritin Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 86.6 ng/mL | Standard Deviation 59.6 |
Secondary
Glucose Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Glucose Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 88.2 mg/dL | Standard Deviation 7.53 |
| Albumin-Co Fraction | Glucose Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 82.2 mg/dL | Standard Deviation 10.1 |
| Albumin-Co Fraction | Glucose Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 86.4 mg/dL | Standard Deviation 9.4 |
| Albumin-Co Fraction | Glucose Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 83.2 mg/dL | Standard Deviation 9.91 |
| Albumin-Co Fraction | Glucose Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 79.6 mg/dL | Standard Deviation 14.5 |
| Albumin-Co Fraction | Glucose Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 88.4 mg/dL | Standard Deviation 15.1 |
| SI After Cobalt Supplementation | Glucose Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 90.6 mg/dL | Standard Deviation 2.97 |
| SI After Cobalt Supplementation | Glucose Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 89.9 mg/dL | Standard Deviation 13 |
| SI After Cobalt Supplementation | Glucose Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 87.4 mg/dL | Standard Deviation 13.8 |
| SI After Cobalt Supplementation | Glucose Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 83.4 mg/dL | Standard Deviation 9.76 |
| SI After Cobalt Supplementation | Glucose Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 79.4 mg/dL | Standard Deviation 9.5 |
| SI After Cobalt Supplementation | Glucose Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 81.2 mg/dL | Standard Deviation 26.1 |
Secondary
HDL Cholesterol Levels After 3 Months of Cobalt Supplementation
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. HDL cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.
Time frame: Study volunteers were assessed before and at the end of cobalt supplementation
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | HDL Cholesterol Levels After 3 Months of Cobalt Supplementation | Baseline | 85.2 mg/dL | Standard Deviation 19 |
| Albumin-Co Fraction | HDL Cholesterol Levels After 3 Months of Cobalt Supplementation | Days 88 and 90 | 78.4 mg/dL | Standard Deviation 23.1 |
| SI After Cobalt Supplementation | HDL Cholesterol Levels After 3 Months of Cobalt Supplementation | Baseline | 50.2 mg/dL | Standard Deviation 14.1 |
| SI After Cobalt Supplementation | HDL Cholesterol Levels After 3 Months of Cobalt Supplementation | Days 88 and 90 | 50.6 mg/dL | Standard Deviation 11.9 |
Secondary
Hematocrit Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Hematocrit Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 41.0 Percentage | Standard Deviation 1.14 |
| Albumin-Co Fraction | Hematocrit Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 41.7 Percentage | Standard Deviation 2.17 |
| Albumin-Co Fraction | Hematocrit Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 40.9 Percentage | Standard Deviation 2 |
| Albumin-Co Fraction | Hematocrit Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 40.9 Percentage | Standard Deviation 2.42 |
| Albumin-Co Fraction | Hematocrit Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 41.5 Percentage | Standard Deviation 1.68 |
| Albumin-Co Fraction | Hematocrit Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 40.9 Percentage | Standard Deviation 1.15 |
| SI After Cobalt Supplementation | Hematocrit Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 45.1 Percentage | Standard Deviation 2.53 |
| SI After Cobalt Supplementation | Hematocrit Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 45.7 Percentage | Standard Deviation 1.11 |
| SI After Cobalt Supplementation | Hematocrit Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 45.0 Percentage | Standard Deviation 2.54 |
| SI After Cobalt Supplementation | Hematocrit Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 46.3 Percentage | Standard Deviation 2.75 |
| SI After Cobalt Supplementation | Hematocrit Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 45.0 Percentage | Standard Deviation 2.9 |
| SI After Cobalt Supplementation | Hematocrit Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 45.8 Percentage | Standard Deviation 2.39 |
Secondary
Hemoglobin Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Hemoglobin Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 13.5 g/dL | Standard Deviation 0.43 |
| Albumin-Co Fraction | Hemoglobin Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 13.3 g/dL | Standard Deviation 0.5 |
| Albumin-Co Fraction | Hemoglobin Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 13.2 g/dL | Standard Deviation 0.37 |
| Albumin-Co Fraction | Hemoglobin Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 13.1 g/dL | Standard Deviation 0.31 |
| Albumin-Co Fraction | Hemoglobin Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 13.4 g/dL | Standard Deviation 0.75 |
| Albumin-Co Fraction | Hemoglobin Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 13.1 g/dL | Standard Deviation 0.61 |
| SI After Cobalt Supplementation | Hemoglobin Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 14.9 g/dL | Standard Deviation 0.78 |
| SI After Cobalt Supplementation | Hemoglobin Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 14.9 g/dL | Standard Deviation 0.93 |
| SI After Cobalt Supplementation | Hemoglobin Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 14.9 g/dL | Standard Deviation 0.76 |
| SI After Cobalt Supplementation | Hemoglobin Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 14.8 g/dL | Standard Deviation 0.82 |
| SI After Cobalt Supplementation | Hemoglobin Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 15.0 g/dL | Standard Deviation 0.4 |
| SI After Cobalt Supplementation | Hemoglobin Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 15.1 g/dL | Standard Deviation 0.74 |
Secondary
Protein Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Protein Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 7.11 g/dL | Standard Deviation 0.33 |
| Albumin-Co Fraction | Protein Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 7.00 g/dL | Standard Deviation 0.35 |
| Albumin-Co Fraction | Protein Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 7.08 g/dL | Standard Deviation 0.28 |
| Albumin-Co Fraction | Protein Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 7.02 g/dL | Standard Deviation 0.38 |
| Albumin-Co Fraction | Protein Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 6.96 g/dL | Standard Deviation 0.48 |
| Albumin-Co Fraction | Protein Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n =5, 5) | 7.04 g/dL | Standard Deviation 0.29 |
| SI After Cobalt Supplementation | Protein Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 7.28 g/dL | Standard Deviation 0.33 |
| SI After Cobalt Supplementation | Protein Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 7.26 g/dL | Standard Deviation 0.3 |
| SI After Cobalt Supplementation | Protein Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 7.14 g/dL | Standard Deviation 0.11 |
| SI After Cobalt Supplementation | Protein Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 7.24 g/dL | Standard Deviation 0.3 |
| SI After Cobalt Supplementation | Protein Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n =5, 5) | 7.32 g/dL | Standard Deviation 0.41 |
| SI After Cobalt Supplementation | Protein Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 7.16 g/dL | Standard Deviation 0.31 |
Secondary
Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 4.42 million cells/µL | Standard Deviation 0.28 |
| Albumin-Co Fraction | Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 4.28 million cells/µL | Standard Deviation 0.18 |
| Albumin-Co Fraction | Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 4.3 million cells/µL | Standard Deviation 0.21 |
| Albumin-Co Fraction | Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 4.32 million cells/µL | Standard Deviation 0.27 |
| Albumin-Co Fraction | Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 4.42 million cells/µL | Standard Deviation 0.37 |
| Albumin-Co Fraction | Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 4.38 million cells/µL | Standard Deviation 0.31 |
| SI After Cobalt Supplementation | Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 4.77 million cells/µL | Standard Deviation 0.24 |
| SI After Cobalt Supplementation | Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 4.71 million cells/µL | Standard Deviation 0.2 |
| SI After Cobalt Supplementation | Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 4.72 million cells/µL | Standard Deviation 0.32 |
| SI After Cobalt Supplementation | Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 4.70 million cells/µL | Standard Deviation 0.2 |
| SI After Cobalt Supplementation | Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 4.79 million cells/µL | Standard Deviation 0.21 |
| SI After Cobalt Supplementation | Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 4.81 million cells/µL | Standard Deviation 0.18 |
Secondary
T4 Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation.Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | T4 Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 1.10 ng/dL | Standard Deviation 0.11 |
| Albumin-Co Fraction | T4 Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 1.16 ng/dL | Standard Deviation 0.11 |
| Albumin-Co Fraction | T4 Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 1.12 ng/dL | Standard Deviation 0.11 |
| Albumin-Co Fraction | T4 Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 1.08 ng/dL | Standard Deviation 0.18 |
| Albumin-Co Fraction | T4 Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 1.22 ng/dL | Standard Deviation 0.13 |
| Albumin-Co Fraction | T4 Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 1.06 ng/dL | Standard Deviation 0.11 |
| SI After Cobalt Supplementation | T4 Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 1.15 ng/dL | Standard Deviation 0.1 |
| SI After Cobalt Supplementation | T4 Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 1.15 ng/dL | Standard Deviation 0.15 |
| SI After Cobalt Supplementation | T4 Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 1.12 ng/dL | Standard Deviation 0.08 |
| SI After Cobalt Supplementation | T4 Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 1.16 ng/dL | Standard Deviation 0.13 |
| SI After Cobalt Supplementation | T4 Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 1.14 ng/dL | Standard Deviation 0.05 |
| SI After Cobalt Supplementation | T4 Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 1.16 ng/dL | Standard Deviation 0.13 |
Secondary
Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 1.73 mIU/L | Standard Deviation 0.77 |
| Albumin-Co Fraction | Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 1.53 mIU/L | Standard Deviation 1.03 |
| Albumin-Co Fraction | Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 1.65 mIU/L | Standard Deviation 1.08 |
| Albumin-Co Fraction | Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 2.30 mIU/L | Standard Deviation 1.9 |
| Albumin-Co Fraction | Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 1.73 mIU/L | Standard Deviation 0.9 |
| Albumin-Co Fraction | Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 1.55 mIU/L | Standard Deviation 0.63 |
| SI After Cobalt Supplementation | Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 2.30 mIU/L | Standard Deviation 1.93 |
| SI After Cobalt Supplementation | Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 2.35 mIU/L | Standard Deviation 1.72 |
| SI After Cobalt Supplementation | Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 2.24 mIU/L | Standard Deviation 2.02 |
| SI After Cobalt Supplementation | Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 3.35 mIU/L | Standard Deviation 3.82 |
| SI After Cobalt Supplementation | Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 2.33 mIU/L | Standard Deviation 2.35 |
| SI After Cobalt Supplementation | Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 3.11 mIU/L | Standard Deviation 3.65 |
Secondary
Total Cholesterol Levels After 3 Months of Cobalt Supplementation
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Total cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.
Time frame: Study volunteers were assessed before and at the end of cobalt supplementation
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Total Cholesterol Levels After 3 Months of Cobalt Supplementation | Baseline | 209 mg/dL | Standard Deviation 31.7 |
| Albumin-Co Fraction | Total Cholesterol Levels After 3 Months of Cobalt Supplementation | Days 88 and 90 | 220 mg/dL | Standard Deviation 54.6 |
| SI After Cobalt Supplementation | Total Cholesterol Levels After 3 Months of Cobalt Supplementation | Baseline | 179 mg/dL | Standard Deviation 26.6 |
| SI After Cobalt Supplementation | Total Cholesterol Levels After 3 Months of Cobalt Supplementation | Days 88 and 90 | 188 mg/dL | Standard Deviation 46.6 |
Secondary
Total Iron Levels After 1, 2 and 3 Months of Dosing
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Total Iron Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 77.4 µg/dL | Standard Deviation 21.5 |
| Albumin-Co Fraction | Total Iron Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 88.4 µg/dL | Standard Deviation 12.6 |
| Albumin-Co Fraction | Total Iron Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 77.6 µg/dL | Standard Deviation 51.4 |
| Albumin-Co Fraction | Total Iron Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 84.6 µg/dL | Standard Deviation 19.4 |
| Albumin-Co Fraction | Total Iron Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 64 µg/dL | Standard Deviation 11.6 |
| Albumin-Co Fraction | Total Iron Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 79.2 µg/dL | Standard Deviation 21 |
| SI After Cobalt Supplementation | Total Iron Levels After 1, 2 and 3 Months of Dosing | 2 wk postdose (n = 5, 5) | 111 µg/dL | Standard Deviation 42.8 |
| SI After Cobalt Supplementation | Total Iron Levels After 1, 2 and 3 Months of Dosing | Baseline (n = 5, 5) | 122 µg/dL | Standard Deviation 26.4 |
| SI After Cobalt Supplementation | Total Iron Levels After 1, 2 and 3 Months of Dosing | Days 29 and 30 (n = 5, 5) | 119 µg/dL | Standard Deviation 39.5 |
| SI After Cobalt Supplementation | Total Iron Levels After 1, 2 and 3 Months of Dosing | Days 57 and 58 (n = 5, 5) | 105 µg/dL | Standard Deviation 47.1 |
| SI After Cobalt Supplementation | Total Iron Levels After 1, 2 and 3 Months of Dosing | Days 88 and 90 (n = 5, 5) | 82.6 µg/dL | Standard Deviation 32.6 |
| SI After Cobalt Supplementation | Total Iron Levels After 1, 2 and 3 Months of Dosing | 1 wk postdose (n = 5, 5) | 115 µg/dL | Standard Deviation 37.1 |
Secondary
Triglyceride Levels After 3 Months of Cobalt Supplementation
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Triglyceride levels were assessed before cobalt dietary supplementation and after three months of supplementation.
Time frame: Study volunteers were assessed before and at the end of cobalt supplementation
Population: Participants that completed three months of cobalt supplementation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | Triglyceride Levels After 3 Months of Cobalt Supplementation | Baseline | 105 mg/dL | Standard Deviation 41.3 |
| Albumin-Co Fraction | Triglyceride Levels After 3 Months of Cobalt Supplementation | Days 88 and 90 | 95.6 mg/dL | Standard Deviation 29.6 |
| SI After Cobalt Supplementation | Triglyceride Levels After 3 Months of Cobalt Supplementation | Baseline | 113 mg/dL | Standard Deviation 51.1 |
| SI After Cobalt Supplementation | Triglyceride Levels After 3 Months of Cobalt Supplementation | Days 88 and 90 | 122 mg/dL | Standard Deviation 71.5 |
Secondary
White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Time frame: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)
Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Albumin-Co Fraction | White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | Baseline (n = 5, 5) | 6.46 thousand cells/µL | Standard Deviation 0.94 |
| Albumin-Co Fraction | White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | Days 29 and 30 (n = 5, 5) | 6.44 thousand cells/µL | Standard Deviation 1.09 |
| Albumin-Co Fraction | White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | Days 57 and 58 (n = 5, 5) | 6.36 thousand cells/µL | Standard Deviation 0.88 |
| Albumin-Co Fraction | White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | Days 88 and 90 (n = 5, 5) | 5.98 thousand cells/µL | Standard Deviation 1.24 |
| Albumin-Co Fraction | White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | 1 wk postdose (n = 5, 5) | 6.1 thousand cells/µL | Standard Deviation 1.51 |
| Albumin-Co Fraction | White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | 2 wk postdose (n = 5, 5) | 6.34 thousand cells/µL | Standard Deviation 0.92 |
| SI After Cobalt Supplementation | White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | 1 wk postdose (n = 5, 5) | 7.1 thousand cells/µL | Standard Deviation 1.78 |
| SI After Cobalt Supplementation | White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | Baseline (n = 5, 5) | 6.79 thousand cells/µL | Standard Deviation 1.12 |
| SI After Cobalt Supplementation | White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | Days 88 and 90 (n = 5, 5) | 6.34 thousand cells/µL | Standard Deviation 0.75 |
| SI After Cobalt Supplementation | White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | Days 29 and 30 (n = 5, 5) | 6.42 thousand cells/µL | Standard Deviation 0.79 |
| SI After Cobalt Supplementation | White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | 2 wk postdose (n = 5, 5) | 6.42 thousand cells/µL | Standard Deviation 0.46 |
| SI After Cobalt Supplementation | White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation | Days 57 and 58 (n = 5, 5) | 6.94 thousand cells/µL | Standard Deviation 0.94 |