Vitamin B12 Deficiency
Conditions
Keywords
hemodialysis, viatmin B12 deficiency, Epogen
Brief summary
Vitamin B12 has several important functions in the body, two of which are production of red blood cells and the maintenance of a healthy nervous system. When vitamin B12 is deficient, abnormal red blood cells form. These cells are called megaloblasts. The end result is a decreased number of red blood cells; a condition called anemia. Some symptoms of anemia include fatigue, weakness, shortness of breath, and pallor. Vitamin B12 is also important in maintaining a healthy nervous system. Nerves are surrounded by an insulating material that helps them conduct impulses. Patients with low B12 levels who receive this vitamin in injection form, state that there quality of life is better. Anemia in Hemodialysis patients is treated with Epogen, a synthetic material which helps your body make blood cells. The investigators believe that if you have a low vitamin B12 level in your blood and the investigators give you the vitamin during dialysis your requirement for epogen will be lower and you will be able to produce blood cells better. When evaluating for Vitamin B12 deficiency a special test is needed called methylmalonic acid level (MMA). This is a blood test that will be performed and when this level is high and your vitamin B12 level is in the low normal range the investigators can make a diagnosis of vitamin B12 deficiency.
Detailed description
BACKGROUND: Vitamin B12 deficiency may have deleterious effects on end stage renal disease (ESRD) patients on maintenance hemodialysis, and may increase erythropoietin stimulating agent (ESA) resistance, yet little is known about its prevalence in this population. METHODS: Serum vitamin B12 and methylmalonic acid (MMA) levels were drawn from ESRD patients prior to hemodialysis. All patients with MMA levels greater than 800 nmol/L had peripheral smears evaluated for B12 deficiency. Those with confirmatory smears were considered to be deficient and received intramuscular vitamin B12 injections for 4 months. Post-treatment MMA levels and smears were obtained. Erythropoietin dosages were monitored throughout the treatment period.
Interventions
DRUGVitamin B12
Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment.
Sponsors
Staten Island University Hospital
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* · Patients on Hemodialysis for at least 6 months * Patients on stable dose of epogen and iron supplementation for at least 1 month prior to B12 and MMA assay.
Exclusion criteria
* · On B12 treatment * Hematological Cancer * Methotrexate use * Alcohol use greater then 2 drinks per day * Vegetarian Diet * Gastric Surgery * Inflammatory Bowel Disease * Pernicious Anemia * Recent transfusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Amount of Epogen Required | Baseline and 4 months | The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | 3 month | The scoring procedure for the KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease),first transforms the raw precoded numeric values of items to a 0-100 possible range with higher transformed scores reflecting a better quality of life. Each item is put on a 0 to100 range so that the lowest and highest possible scores are set at 0 and100, respectively. The results entered in the outcome data is the mean absolute difference between the mean pre-test score and the mean post-test score. |
Countries
United States
Participant flow
Recruitment details
Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
Participants by arm
| Arm | Count |
|---|---|
| Vitamin B12 Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | MMA was not over 800mg/dL | 75 |
Baseline characteristics
| Characteristic | Vitamin B12 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| Age, Continuous | 63.43 years STANDARD_DEVIATION 14.6 |
| Region of Enrollment United States | 57 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 |
Outcome results
Primary
Change in Amount of Epogen Required
The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients
Time frame: Baseline and 4 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamin B12 | Change in Amount of Epogen Required | -16,572 unit/ml |
Secondary
Change in Quality of Life
The scoring procedure for the KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease),first transforms the raw precoded numeric values of items to a 0-100 possible range with higher transformed scores reflecting a better quality of life. Each item is put on a 0 to100 range so that the lowest and highest possible scores are set at 0 and100, respectively. The results entered in the outcome data is the mean absolute difference between the mean pre-test score and the mean post-test score.
Time frame: 3 month
Population: Subjects were asked to complete a KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease), once prior to therapy, and then again at the end of 3 months when therapy (when therapy is completed), was completed. Pre and post results will be compared.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vitamin B12 | Change in Quality of Life | Work status (pre-test) | 26.67 Scores on a Scale | Standard Deviation 32 |
| Vitamin B12 | Change in Quality of Life | SF-12 physical composite (post-test) | 36.12 Scores on a Scale | Standard Deviation 9.44 |
| Vitamin B12 | Change in Quality of Life | SF-12 mental composite (pre-test) | 41.88 Scores on a Scale | Standard Deviation 11.45 |
| Vitamin B12 | Change in Quality of Life | SF-12 mental composite (post-test) | 44.83 Scores on a Scale | Standard Deviation 11.18 |
| Vitamin B12 | Change in Quality of Life | Effects of kidney disease (pre to post change) | 2.29 Scores on a Scale | Standard Deviation 9.99 |
| Vitamin B12 | Change in Quality of Life | Social Function (pre-test) | 56.67 Scores on a Scale | Standard Deviation 29.07 |
| Vitamin B12 | Change in Quality of Life | Social Function (post-test) | 67.50 Scores on a Scale | Standard Deviation 24.91 |
| Vitamin B12 | Change in Quality of Life | Symptom/problem list (pre-test) | 76.62 Scores on a Scale | Standard Deviation 18.6 |
| Vitamin B12 | Change in Quality of Life | Symptom/problem list (post-test) | 75.69 Scores on a Scale | Standard Deviation 19.98 |
| Vitamin B12 | Change in Quality of Life | Effects of kidney disease (pre-test) | 52.29 Scores on a Scale | Standard Deviation 26.08 |
| Vitamin B12 | Change in Quality of Life | Effects of kidney disease (post-test) | 54.58 Scores on a Scale | Standard Deviation 26.96 |
| Vitamin B12 | Change in Quality of Life | Burden of kidney disease pre-test | 43.75 Scores on a Scale | Standard Deviation 31.25 |
| Vitamin B12 | Change in Quality of Life | Burden of kidney disease (post-test) | 37.50 Scores on a Scale | Standard Deviation 29.6 |
| Vitamin B12 | Change in Quality of Life | Work status (post-test) | 16.67 Scores on a Scale | Standard Deviation 30.86 |
| Vitamin B12 | Change in Quality of Life | Cognitive function (pre-test) | 71.11 Scores on a Scale | Standard Deviation 28.91 |
| Vitamin B12 | Change in Quality of Life | Cognitive function (post-test) | 72.44 Scores on a Scale | Standard Deviation 29.26 |
| Vitamin B12 | Change in Quality of Life | Quality of social interaction (pre-test) | 70.67 Scores on a Scale | Standard Deviation 26.04 |
| Vitamin B12 | Change in Quality of Life | Quality of social interaction (post-test) | 79.11 Scores on a Scale | Standard Deviation 18.15 |
| Vitamin B12 | Change in Quality of Life | Sexual function (pre-test) | 87.50 Scores on a Scale | Standard Deviation 17.68 |
| Vitamin B12 | Change in Quality of Life | Sexual function (post-test) | 100.00 Scores on a Scale | Standard Deviation 0 |
| Vitamin B12 | Change in Quality of Life | Sleep (pre-test) | 51.00 Scores on a Scale | Standard Deviation 23.81 |
| Vitamin B12 | Change in Quality of Life | Sleep (post-test) | 51.33 Scores on a Scale | Standard Deviation 24.03 |
| Vitamin B12 | Change in Quality of Life | Social support (pre-test) | 77.78 Scores on a Scale | Standard Deviation 32.53 |
| Vitamin B12 | Change in Quality of Life | Social support (post-test) | 77.78 Scores on a Scale | Standard Deviation 29.99 |
| Vitamin B12 | Change in Quality of Life | Dialysis staff encouragement (pre-test) | 83.33 Scores on a Scale | Standard Deviation 15.43 |
| Vitamin B12 | Change in Quality of Life | Dialysis staff encouragement (post-test) | 82.50 Scores on a Scale | Standard Deviation 16.9 |
| Vitamin B12 | Change in Quality of Life | Overall health (pre-test) | 54.67 Scores on a Scale | Standard Deviation 24.46 |
| Vitamin B12 | Change in Quality of Life | Overall health (post-test) | 60.00 Scores on a Scale | Standard Deviation 27.77 |
| Vitamin B12 | Change in Quality of Life | Patient satisfaction (pre-test) | 71.11 Scores on a Scale | Standard Deviation 22.24 |
| Vitamin B12 | Change in Quality of Life | Patient satisfaction (post-test) | 62.22 Scores on a Scale | Standard Deviation 17.21 |
| Vitamin B12 | Change in Quality of Life | Physical functioning (pre-test) | 39.33 Scores on a Scale | Standard Deviation 30.41 |
| Vitamin B12 | Change in Quality of Life | Physical functioning (post-test) | 37.00 Scores on a Scale | Standard Deviation 27.37 |
| Vitamin B12 | Change in Quality of Life | Role-physical (pre-test) | 28.33 Scores on a Scale | Standard Deviation 38.81 |
| Vitamin B12 | Change in Quality of Life | Role-physical (post-test) | 40.00 Scores on a Scale | Standard Deviation 40.97 |
| Vitamin B12 | Change in Quality of Life | Pain (pre-test) | 55.83 Scores on a Scale | Standard Deviation 36.57 |
| Vitamin B12 | Change in Quality of Life | Pain (post-test) | 65.83 Scores on a Scale | Standard Deviation 33.54 |
| Vitamin B12 | Change in Quality of Life | General health (pre-test) | 36.92 Scores on a Scale | Standard Deviation 17.97 |
| Vitamin B12 | Change in Quality of Life | General health (post-test) | 44.33 Scores on a Scale | Standard Deviation 24.56 |
| Vitamin B12 | Change in Quality of Life | Emotional well-being (pre-test) | 68.00 Scores on a Scale | Standard Deviation 21.43 |
| Vitamin B12 | Change in Quality of Life | Emotional well-being (post-test) | 64.00 Scores on a Scale | Standard Deviation 20.51 |
| Vitamin B12 | Change in Quality of Life | Role-emotional (pre-test) | 35.56 Scores on a Scale | Standard Deviation 44.48 |
| Vitamin B12 | Change in Quality of Life | Role-emotional (post-test) | 55.56 Scores on a Scale | Standard Deviation 46.58 |
| Vitamin B12 | Change in Quality of Life | Energy/fatigue (pre-test) | 40.33 Scores on a Scale | Standard Deviation 27.48 |
| Vitamin B12 | Change in Quality of Life | Energy/fatigue (post-test) | 48.00 Scores on a Scale | Standard Deviation 17.61 |
| Vitamin B12 | Change in Quality of Life | SF-12 physical composite (pre-test) | 34.06 Scores on a Scale | Standard Deviation 8.81 |
| Vitamin B12 | Change in Quality of Life | Social function (pre to post change) | 10.83 Scores on a Scale | Standard Deviation 19.4 |
| Vitamin B12 | Change in Quality of Life | Symptom/problem list (pre to post change) | -3.13 Scores on a Scale | Standard Deviation 14.72 |
| Vitamin B12 | Change in Quality of Life | Burden of kidney disease (pre to post change) | -6.25 Scores on a Scale | Standard Deviation 17.52 |
| Vitamin B12 | Change in Quality of Life | Work status (pre to post change) | -10.00 Scores on a Scale | Standard Deviation 20.7 |
| Vitamin B12 | Change in Quality of Life | Cognitive function (pre to post change) | 1.33 Scores on a Scale | Standard Deviation 28.75 |
| Vitamin B12 | Change in Quality of Life | Quality of social interaction (pre to post change) | 8.44 Scores on a Scale | Standard Deviation 25.63 |
| Vitamin B12 | Change in Quality of Life | Sleep (pre to post change) | 0.33 Scores on a Scale | Standard Deviation 20.81 |
| Vitamin B12 | Change in Quality of Life | Social support (pre to post change) | 0.00 Scores on a Scale | Standard Deviation 39.34 |
| Vitamin B12 | Change in Quality of Life | Dialysis staff encouragement (pre to post change) | -0.83 Scores on a Scale | Standard Deviation 21.89 |
| Vitamin B12 | Change in Quality of Life | Overall health (pre to post change) | 5.33 Scores on a Scale | Standard Deviation 19.95 |
| Vitamin B12 | Change in Quality of Life | Patient satisfaction (pre to post change) | -8.89 Scores on a Scale | Standard Deviation 15.26 |
| Vitamin B12 | Change in Quality of Life | Physical functioning (pre to post change) | -2.33 Scores on a Scale | Standard Deviation 17.1 |
| Vitamin B12 | Change in Quality of Life | Role-physical (pre to post change) | 11.67 Scores on a Scale | Standard Deviation 43.16 |
| Vitamin B12 | Change in Quality of Life | Pain (pre to post change) | 10.00 Scores on a Scale | Standard Deviation 36.29 |
| Vitamin B12 | Change in Quality of Life | General health (pre to post change) | 7.42 Scores on a Scale | Standard Deviation 15.81 |
| Vitamin B12 | Change in Quality of Life | Emotional well-being (pre to post change) | -4.00 Scores on a Scale | Standard Deviation 23.71 |
| Vitamin B12 | Change in Quality of Life | Role-emotional (pre to post change) | 20.00 Scores on a Scale | Standard Deviation 46.8 |
| Vitamin B12 | Change in Quality of Life | Energy/fatigue (pre to post change) | 7.67 Scores on a Scale | Standard Deviation 21.29 |
| Vitamin B12 | Change in Quality of Life | SF-12 physical composite (pre to post change) | 2.06 Scores on a Scale | Standard Deviation 8.63 |
| Vitamin B12 | Change in Quality of Life | SF-12 mental composite (pre to post change) | 2.94 Scores on a Scale | Standard Deviation 9.84 |
p-value: 0.047Wilcoxon signed-rank test
p-value: 0.688Wilcoxon signed-rank test
p-value: 0.772Wilcoxon signed-rank test
p-value: 0.301Wilcoxon signed-rank test
p-value: 0.25Wilcoxon signed-rank test
p-value: 0.895Wilcoxon signed-rank test
p-value: 0.281Wilcoxon signed-rank test
p-value: 1Wilcoxon signed-rank test
p-value: 1Wilcoxon signed-rank test
p-value: 0.943Wilcoxon signed-rank test
p-value: 1Wilcoxon signed-rank test
p-value: 0.09Wilcoxon signed-rank test
p-value: 0.391Wilcoxon signed-rank test
p-value: 0.438Wilcoxon signed-rank test
p-value: 0.424Wilcoxon signed-rank test
p-value: 0.169Wilcoxon signed-rank test
p-value: 0.858Wilcoxon signed-rank test
p-value: 0.156Wilcoxon signed-rank test
p-value: 0.084Wilcoxon signed-rank test
p-value: 0.583Wilcoxon signed-rank test
p-value: 0.358Wilcoxon signed-rank test