Iron-deficiency
Conditions
Brief summary
Hypothesis: Synergistic effect of pre-biotics and iron fortificants will enhance the bioavailability of iron; thereby improving the body iron reserves. A double blind, randomized controlled trail will be conducted on iron deficient female adults (age 18-25 years) in order to determine the synergistic effect of pre-biotics and iron fortificants in anemic human subjects. 75 iron deficient females will be randomly divided into 5 groups (D0, D1, D2, D3 and D4), each having 15 study subjects and will be given varying doses of FeSO4 and NaFeEDTA and Inulin and GOS. Blood samples will be collected from overnight fasted women from each group on monthly basis up to three months. Various biomarkers for iron absorption, LFTs, RFTs, and Immunoglobulins will be estimated.
Detailed description
Study Design A double blind, randomized controlled trial will be used for the purpose of this study. Study Site The study will be conducted in Islamabad and/or Lahore, depending on the availability of the required sample size with the desired profiles. Study Duration The trial will last for 12 weeks. Study Population The study population will consist of university going iron deficient female adults (age 18-25 years). Inclusion and Exclusion Criteria Inclusion Criteria All willing anemic female adults without any chronic diseases such as diabetes or hypertension will be included in the study. Exclusion Criteria Married females or those with chronic diseases or those already taking iron and/or prebiotic supplements will be excluded from the study. Sampling Sampling Technique The technique of convenience sampling will be used for the current study. Sample Size Each group will consist of 15 study subjects for the purpose of convenience and the total sample size will be 75. Treatment Plan For this phase of the study, 4 best treatment combinations of pre-biotics (Inulin & Galactooligosaccharides) and iron fortificants (FeSO4 and NaFeEDTA) will be chosen. Study participants will be randomly chosen to receive either the best treatment combination 1, 2, 3, 4 or the placebo for 12 weeks on daily basis. Efficacy Trials Blood samples will be collected from overnight fasted women from each group on monthly basis up to three months. Hematological analysis The collected blood from respective groups will be assessed for hematological analysis. Iron Biomarkers Obtained sera will also be analyzed for blood serum biomarkers like serum iron, folate, ferritin, transferrin saturation fraction & TIBC. Liver function tests Liver function tests including AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase), ALP (Alkaline Phosphatase) and Total Bilirubin will be conducted Renal function tests Blood urea (GLDH-method) and creatinine (Jaffe-method) levels will be determined using commercial kits. Immunoglobulins Immunoglobulins, including Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, and Immunoglobulin M will be determined using the technique of ELISA (Enzyme linked Immunosorbent Assay).
Interventions
COMBINATION_PRODUCTPrebiotic + Iron Forificant
A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Sponsors
University of Veterinary and Animal Sciences, Lahore - Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* All willing anemic female adults without any chronic diseases such as diabetes or hypertension will be included in the study.
Exclusion criteria
* Married females or those with chronic diseases or those already taking iron and/or prebiotic supplements will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Hemoglobin Concentration From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Hematocrit in Concentration From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Mean Corpuscular Volume From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Serum Iron Levels From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Serum Folate Levels From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Serum Ferritin Levels From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Serum Transferrin Levels From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Change in Immunoglobulins (IgG) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Immunoglobulins (IgM) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Immunoglobulins (IgA) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Liver Functions Tests (ALT) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Liver Functions Tests (AST) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Liver Functions Tests (ALP) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
| Change in Immunoglobulins (IgE) From Baseline to 90 Days | Baseline, 30 days, 60 days, 90 days |
Countries
Pakistan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Only Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects. | 15 |
| Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 10 ppm NaFeEDTA was given to the study subjects. | 15 |
| Prebiotic Inulin & Iron Salt NaFeEDTA (2) Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 20 ppm NaFeEDTA was given to the study subjects. | 15 |
| Prebiotic Inulin & Iron Salt FeS04 Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 30 ppm FeSO4 was given to the study subjects. | 15 |
| Prebiotic GOS & Iron Salt NaFeEDTA Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg GOS and 20 ppm NaFeEDTA was given to the study subjects. | 15 |
| Total | 75 |
Baseline characteristics
| Characteristic | Total | Prebiotic Inulin & Iron Salt NaFeEDTA | Prebiotic Inulin & Iron Salt NaFeEDTA (2) | Prebiotic Inulin & Iron Salt FeS04 | Placebo Only | Prebiotic GOS & Iron Salt NaFeEDTA |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — | — |
| Region of Enrollment Pakistan | 75 participants | 15 participants | 15 participants | 15 participants | 15 participants | 15 participants |
| Sex: Female, Male Female | 75 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in Hematocrit in Concentration From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Hematocrit in Concentration From Baseline to 90 Days | Baseline | 30.26 % of RBCs in blood | Standard Deviation 0.17 |
| Placebo Only | Change in Hematocrit in Concentration From Baseline to 90 Days | 30 days | 31.62 % of RBCs in blood | Standard Deviation 0.04 |
| Placebo Only | Change in Hematocrit in Concentration From Baseline to 90 Days | 60 days | 32.65 % of RBCs in blood | Standard Deviation 0.03 |
| Placebo Only | Change in Hematocrit in Concentration From Baseline to 90 Days | 90 days | 34.36 % of RBCs in blood | Standard Deviation 0.16 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Hematocrit in Concentration From Baseline to 90 Days | Baseline | 33.76 % of RBCs in blood | Standard Deviation 0.19 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Hematocrit in Concentration From Baseline to 90 Days | 90 days | 36.43 % of RBCs in blood | Standard Deviation 0.07 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Hematocrit in Concentration From Baseline to 90 Days | 30 days | 34.84 % of RBCs in blood | Standard Deviation 0.12 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Hematocrit in Concentration From Baseline to 90 Days | 60 days | 35.14 % of RBCs in blood | Standard Deviation 0.1 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Hematocrit in Concentration From Baseline to 90 Days | 90 days | 36.17 % of RBCs in blood | Standard Deviation 0.07 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Hematocrit in Concentration From Baseline to 90 Days | 30 days | 33.72 % of RBCs in blood | Standard Deviation 0.08 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Hematocrit in Concentration From Baseline to 90 Days | 60 days | 34.76 % of RBCs in blood | Standard Deviation 0.17 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Hematocrit in Concentration From Baseline to 90 Days | Baseline | 32.77 % of RBCs in blood | Standard Deviation 0.07 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Hematocrit in Concentration From Baseline to 90 Days | Baseline | 33.50 % of RBCs in blood | Standard Deviation 0.06 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Hematocrit in Concentration From Baseline to 90 Days | 30 days | 34.59 % of RBCs in blood | Standard Deviation 0.09 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Hematocrit in Concentration From Baseline to 90 Days | 90 days | 36.56 % of RBCs in blood | Standard Deviation 0.06 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Hematocrit in Concentration From Baseline to 90 Days | 60 days | 35.60 % of RBCs in blood | Standard Deviation 0.07 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Hematocrit in Concentration From Baseline to 90 Days | 90 days | 37.86 % of RBCs in blood | Standard Deviation 0.26 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Hematocrit in Concentration From Baseline to 90 Days | 60 days | 35.24 % of RBCs in blood | Standard Deviation 0.06 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Hematocrit in Concentration From Baseline to 90 Days | 30 days | 33.81 % of RBCs in blood | Standard Deviation 0.13 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Hematocrit in Concentration From Baseline to 90 Days | Baseline | 31.50 % of RBCs in blood | Standard Deviation 0.06 |
Primary
Change in Hemoglobin Concentration From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Hemoglobin Concentration From Baseline to 90 Days | Baseline | 11.44 g/dL | Standard Deviation 0.04 |
| Placebo Only | Change in Hemoglobin Concentration From Baseline to 90 Days | 30 days | 11.52 g/dL | Standard Deviation 0.01 |
| Placebo Only | Change in Hemoglobin Concentration From Baseline to 90 Days | 60 days | 11.64 g/dL | Standard Deviation 0.01 |
| Placebo Only | Change in Hemoglobin Concentration From Baseline to 90 Days | 90 days | 11.91 g/dL | Standard Deviation 0.02 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Hemoglobin Concentration From Baseline to 90 Days | 90 days | 12.04 g/dL | Standard Deviation 0.03 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Hemoglobin Concentration From Baseline to 90 Days | Baseline | 11.58 g/dL | Standard Deviation 0.02 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Hemoglobin Concentration From Baseline to 90 Days | 30 days | 11.71 g/dL | Standard Deviation 0.01 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Hemoglobin Concentration From Baseline to 90 Days | 60 days | 11.83 g/dL | Standard Deviation 0.01 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Hemoglobin Concentration From Baseline to 90 Days | 30 days | 11.62 g/dL | Standard Deviation 0.01 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Hemoglobin Concentration From Baseline to 90 Days | 60 days | 11.74 g/dL | Standard Deviation 0.01 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Hemoglobin Concentration From Baseline to 90 Days | Baseline | 11.54 g/dL | Standard Deviation 0.01 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Hemoglobin Concentration From Baseline to 90 Days | 90 days | 11.85 g/dL | Standard Deviation 0.01 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Hemoglobin Concentration From Baseline to 90 Days | 30 days | 11.78 g/dL | Standard Deviation 0.03 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Hemoglobin Concentration From Baseline to 90 Days | Baseline | 11.61 g/dL | Standard Deviation 0.02 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Hemoglobin Concentration From Baseline to 90 Days | 60 days | 11.90 g/dL | Standard Deviation 0.01 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Hemoglobin Concentration From Baseline to 90 Days | 90 days | 12.17 g/dL | Standard Deviation 0.04 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Hemoglobin Concentration From Baseline to 90 Days | 60 days | 11.84 g/dL | Standard Deviation 0.02 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Hemoglobin Concentration From Baseline to 90 Days | 30 days | 11.54 g/dL | Standard Deviation 0.02 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Hemoglobin Concentration From Baseline to 90 Days | Baseline | 11.28 g/dL | Standard Deviation 0.04 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Hemoglobin Concentration From Baseline to 90 Days | 90 days | 12.33 g/dL | Standard Deviation 0.02 |
Primary
Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | Baseline | 31.44 g/dL | Standard Deviation 0.77 |
| Placebo Only | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 30 days | 31.07 g/dL | Standard Deviation 0.74 |
| Placebo Only | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 60 days | 31.70 g/dL | Standard Deviation 0.45 |
| Placebo Only | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 90 days | 32.78 g/dL | Standard Deviation 0.58 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | Baseline | 29.30 g/dL | Standard Deviation 0.79 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 90 days | 33.46 g/dL | Standard Deviation 0.83 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 30 days | 30.30 g/dL | Standard Deviation 1.11 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 60 days | 31.91 g/dL | Standard Deviation 0.59 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 90 days | 33.13 g/dL | Standard Deviation 0.94 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 30 days | 30.08 g/dL | Standard Deviation 0.76 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 60 days | 31.19 g/dL | Standard Deviation 0.94 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | Baseline | 28.06 g/dL | Standard Deviation 0.31 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | Baseline | 29.05 g/dL | Standard Deviation 0.5 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 30 days | 30.74 g/dL | Standard Deviation 0.67 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 90 days | 34.15 g/dL | Standard Deviation 1.06 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 60 days | 33.42 g/dL | Standard Deviation 0.96 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 90 days | 36.91 g/dL | Standard Deviation 0.98 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 60 days | 34.25 g/dL | Standard Deviation 0.85 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | 30 days | 30.67 g/dL | Standard Deviation 0.77 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days | Baseline | 28.51 g/dL | Standard Deviation 0.38 |
Primary
Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 60 days | 24.47 pg | Standard Deviation 1 |
| Placebo Only | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | Baseline | 21.94 pg | Standard Deviation 1.35 |
| Placebo Only | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 30 days | 23.24 pg | Standard Deviation 1.14 |
| Placebo Only | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 90 days | 25.09 pg | Standard Deviation 0.89 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 60 days | 25.05 pg | Standard Deviation 0.45 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 90 days | 26.76 pg | Standard Deviation 0.59 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 30 days | 24.83 pg | Standard Deviation 0.86 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | Baseline | 23.63 pg | Standard Deviation 1.02 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 90 days | 26.28 pg | Standard Deviation 0.51 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 60 days | 24.29 pg | Standard Deviation 0.69 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | Baseline | 20.63 pg | Standard Deviation 0.79 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 30 days | 21.86 pg | Standard Deviation 0.74 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 30 days | 25.31 pg | Standard Deviation 1.08 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | Baseline | 24.02 pg | Standard Deviation 0.69 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 90 days | 26.93 pg | Standard Deviation 0.26 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 60 days | 26.47 pg | Standard Deviation 0.28 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 90 days | 30.75 pg | Standard Deviation 0.81 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | Baseline | 24.56 pg | Standard Deviation 0.79 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 60 days | 28.26 pg | Standard Deviation 0.88 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days | 30 days | 27.42 pg | Standard Deviation 0.66 |
Primary
Change in Mean Corpuscular Volume From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Mean Corpuscular Volume From Baseline to 90 Days | Baseline | 68.53 fL | Standard Deviation 0.11 |
| Placebo Only | Change in Mean Corpuscular Volume From Baseline to 90 Days | 30 days | 70.46 fL | Standard Deviation 0.29 |
| Placebo Only | Change in Mean Corpuscular Volume From Baseline to 90 Days | 60 days | 72.72 fL | Standard Deviation 0.09 |
| Placebo Only | Change in Mean Corpuscular Volume From Baseline to 90 Days | 90 days | 77.09 fL | Standard Deviation 0.15 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Mean Corpuscular Volume From Baseline to 90 Days | Baseline | 69.56 fL | Standard Deviation 0.11 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Mean Corpuscular Volume From Baseline to 90 Days | 90 days | 78.64 fL | Standard Deviation 0.17 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Mean Corpuscular Volume From Baseline to 90 Days | 30 days | 71.63 fL | Standard Deviation 0.24 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Mean Corpuscular Volume From Baseline to 90 Days | 60 days | 75.11 fL | Standard Deviation 0.49 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Mean Corpuscular Volume From Baseline to 90 Days | 90 days | 83.77 fL | Standard Deviation 0.13 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Mean Corpuscular Volume From Baseline to 90 Days | 30 days | 74.70 fL | Standard Deviation 0.17 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Mean Corpuscular Volume From Baseline to 90 Days | 60 days | 80.18 fL | Standard Deviation 0.17 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Mean Corpuscular Volume From Baseline to 90 Days | Baseline | 73.79 fL | Standard Deviation 0.19 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Mean Corpuscular Volume From Baseline to 90 Days | Baseline | 76.61 fL | Standard Deviation 0.13 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Mean Corpuscular Volume From Baseline to 90 Days | 30 days | 78.77 fL | Standard Deviation 0.14 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Mean Corpuscular Volume From Baseline to 90 Days | 90 days | 83.64 fL | Standard Deviation 0.15 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Mean Corpuscular Volume From Baseline to 90 Days | 60 days | 81.82 fL | Standard Deviation 0.17 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Mean Corpuscular Volume From Baseline to 90 Days | 90 days | 85.59 fL | Standard Deviation 0.24 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Mean Corpuscular Volume From Baseline to 90 Days | 60 days | 81.96 fL | Standard Deviation 0.14 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Mean Corpuscular Volume From Baseline to 90 Days | 30 days | 80.03 fL | Standard Deviation 0.13 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Mean Corpuscular Volume From Baseline to 90 Days | Baseline | 78.06 fL | Standard Deviation 0.09 |
Primary
Change in Serum Ferritin Levels From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Serum Ferritin Levels From Baseline to 90 Days | Baseline | 11.76 ng/mL | Standard Deviation 0.11 |
| Placebo Only | Change in Serum Ferritin Levels From Baseline to 90 Days | 30 days | 11.86 ng/mL | Standard Deviation 0.08 |
| Placebo Only | Change in Serum Ferritin Levels From Baseline to 90 Days | 60 days | 11.98 ng/mL | Standard Deviation 0.09 |
| Placebo Only | Change in Serum Ferritin Levels From Baseline to 90 Days | 90 days | 12.04 ng/mL | Standard Deviation 0.17 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Ferritin Levels From Baseline to 90 Days | Baseline | 13.73 ng/mL | Standard Deviation 0.18 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Ferritin Levels From Baseline to 90 Days | 90 days | 16.88 ng/mL | Standard Deviation 0.55 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Ferritin Levels From Baseline to 90 Days | 30 days | 14.09 ng/mL | Standard Deviation 0.53 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Ferritin Levels From Baseline to 90 Days | 60 days | 16.28 ng/mL | Standard Deviation 0.54 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Ferritin Levels From Baseline to 90 Days | 90 days | 15.77 ng/mL | Standard Deviation 0.36 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Ferritin Levels From Baseline to 90 Days | 30 days | 13.59 ng/mL | Standard Deviation 0.34 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Ferritin Levels From Baseline to 90 Days | 60 days | 14.31 ng/mL | Standard Deviation 0.37 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Ferritin Levels From Baseline to 90 Days | Baseline | 13.29 ng/mL | Standard Deviation 0.31 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Ferritin Levels From Baseline to 90 Days | Baseline | 12.03 ng/mL | Standard Deviation 0.09 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Ferritin Levels From Baseline to 90 Days | 30 days | 12.86 ng/mL | Standard Deviation 0.1 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Ferritin Levels From Baseline to 90 Days | 90 days | 15.10 ng/mL | Standard Deviation 0.27 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Ferritin Levels From Baseline to 90 Days | 60 days | 13.37 ng/mL | Standard Deviation 0.14 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Ferritin Levels From Baseline to 90 Days | 90 days | 17.55 ng/mL | Standard Deviation 0.21 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Ferritin Levels From Baseline to 90 Days | 60 days | 14.77 ng/mL | Standard Deviation 0.25 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Ferritin Levels From Baseline to 90 Days | 30 days | 13.56 ng/mL | Standard Deviation 0.24 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Ferritin Levels From Baseline to 90 Days | Baseline | 12.67 ng/mL | Standard Deviation 0.23 |
Primary
Change in Serum Folate Levels From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Serum Folate Levels From Baseline to 90 Days | 90 days | 8.94 ng/mL | Standard Deviation 0.09 |
| Placebo Only | Change in Serum Folate Levels From Baseline to 90 Days | 60 days | 8.88 ng/mL | Standard Deviation 0.09 |
| Placebo Only | Change in Serum Folate Levels From Baseline to 90 Days | 30 days | 8.81 ng/mL | Standard Deviation 0.11 |
| Placebo Only | Change in Serum Folate Levels From Baseline to 90 Days | Baseline | 8.74 ng/mL | Standard Deviation 0.12 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Folate Levels From Baseline to 90 Days | 60 days | 10.31 ng/mL | Standard Deviation 0.15 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Folate Levels From Baseline to 90 Days | Baseline | 9.26 ng/mL | Standard Deviation 0.18 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Folate Levels From Baseline to 90 Days | 30 days | 10.03 ng/mL | Standard Deviation 0.17 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Folate Levels From Baseline to 90 Days | 90 days | 10.74 ng/mL | Standard Deviation 0.16 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Folate Levels From Baseline to 90 Days | 30 days | 8.32 ng/mL | Standard Deviation 0.1 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Folate Levels From Baseline to 90 Days | Baseline | 8.05 ng/mL | Standard Deviation 0.08 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Folate Levels From Baseline to 90 Days | 90 days | 9.46 ng/mL | Standard Deviation 0.13 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Folate Levels From Baseline to 90 Days | 60 days | 8.99 ng/mL | Standard Deviation 0.11 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Folate Levels From Baseline to 90 Days | Baseline | 8.96 ng/mL | Standard Deviation 0.11 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Folate Levels From Baseline to 90 Days | 60 days | 9.75 ng/mL | Standard Deviation 0.13 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Folate Levels From Baseline to 90 Days | 90 days | 10.02 ng/mL | Standard Deviation 0.14 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Folate Levels From Baseline to 90 Days | 30 days | 9.40 ng/mL | Standard Deviation 0.12 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Folate Levels From Baseline to 90 Days | 90 days | 11.01 ng/mL | Standard Deviation 0.17 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Folate Levels From Baseline to 90 Days | 60 days | 10.87 ng/mL | Standard Deviation 0.12 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Folate Levels From Baseline to 90 Days | 30 days | 9.97 ng/mL | Standard Deviation 0.07 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Folate Levels From Baseline to 90 Days | Baseline | 8.20 ng/mL | Standard Deviation 0.05 |
Primary
Change in Serum Iron Levels From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Serum Iron Levels From Baseline to 90 Days | 90 days | 70.93 mcg/dL | Standard Deviation 0.95 |
| Placebo Only | Change in Serum Iron Levels From Baseline to 90 Days | 60 days | 70.25 mcg/dL | Standard Deviation 0.85 |
| Placebo Only | Change in Serum Iron Levels From Baseline to 90 Days | 30 days | 69.17 mcg/dL | Standard Deviation 0.85 |
| Placebo Only | Change in Serum Iron Levels From Baseline to 90 Days | Baseline | 68.41 mcg/dL | Standard Deviation 0.7 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Iron Levels From Baseline to 90 Days | 60 days | 74.34 mcg/dL | Standard Deviation 1.12 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Iron Levels From Baseline to 90 Days | Baseline | 70.97 mcg/dL | Standard Deviation 0.7 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Iron Levels From Baseline to 90 Days | 30 days | 72.34 mcg/dL | Standard Deviation 1.01 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Iron Levels From Baseline to 90 Days | 90 days | 75.36 mcg/dL | Standard Deviation 1.23 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Iron Levels From Baseline to 90 Days | 30 days | 73.95 mcg/dL | Standard Deviation 0.77 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Iron Levels From Baseline to 90 Days | Baseline | 72.65 mcg/dL | Standard Deviation 0.5 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Iron Levels From Baseline to 90 Days | 90 days | 77.42 mcg/dL | Standard Deviation 0.91 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Iron Levels From Baseline to 90 Days | 60 days | 75.50 mcg/dL | Standard Deviation 0.9 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Iron Levels From Baseline to 90 Days | Baseline | 71.41 mcg/dL | Standard Deviation 0.6 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Iron Levels From Baseline to 90 Days | 60 days | 73.96 mcg/dL | Standard Deviation 0.99 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Iron Levels From Baseline to 90 Days | 90 days | 76.16 mcg/dL | Standard Deviation 1.09 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Iron Levels From Baseline to 90 Days | 30 days | 72.62 mcg/dL | Standard Deviation 0.73 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Iron Levels From Baseline to 90 Days | 90 days | 79.10 mcg/dL | Standard Deviation 0.95 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Iron Levels From Baseline to 90 Days | 60 days | 76.61 mcg/dL | Standard Deviation 0.53 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Iron Levels From Baseline to 90 Days | 30 days | 74.51 mcg/dL | Standard Deviation 0.39 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Iron Levels From Baseline to 90 Days | Baseline | 72.60 mcg/dL | Standard Deviation 0.33 |
Primary
Change in Serum Transferrin Levels From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Serum Transferrin Levels From Baseline to 90 Days | 60 days | 16.55 mg/dL | Standard Deviation 0.09 |
| Placebo Only | Change in Serum Transferrin Levels From Baseline to 90 Days | 30 days | 16.74 mg/dL | Standard Deviation 0.04 |
| Placebo Only | Change in Serum Transferrin Levels From Baseline to 90 Days | Baseline | 16.84 mg/dL | Standard Deviation 0.05 |
| Placebo Only | Change in Serum Transferrin Levels From Baseline to 90 Days | 90 days | 16.44 mg/dL | Standard Deviation 0.08 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Transferrin Levels From Baseline to 90 Days | Baseline | 16.74 mg/dL | Standard Deviation 0.09 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Transferrin Levels From Baseline to 90 Days | 90 days | 16.41 mg/dL | Standard Deviation 0.13 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Transferrin Levels From Baseline to 90 Days | 30 days | 16.63 mg/dL | Standard Deviation 0.09 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Serum Transferrin Levels From Baseline to 90 Days | 60 days | 16.52 mg/dL | Standard Deviation 0.11 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Transferrin Levels From Baseline to 90 Days | 60 days | 16.21 mg/dL | Standard Deviation 0.09 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Transferrin Levels From Baseline to 90 Days | 90 days | 16.09 mg/dL | Standard Deviation 0.1 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Transferrin Levels From Baseline to 90 Days | Baseline | 16.38 mg/dL | Standard Deviation 0.08 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Serum Transferrin Levels From Baseline to 90 Days | 30 days | 16.30 mg/dL | Standard Deviation 0.09 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Transferrin Levels From Baseline to 90 Days | 30 days | 16.69 mg/dL | Standard Deviation 0.1 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Transferrin Levels From Baseline to 90 Days | Baseline | 16.79 mg/dL | Standard Deviation 0.07 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Transferrin Levels From Baseline to 90 Days | 90 days | 16.46 mg/dL | Standard Deviation 0.08 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Serum Transferrin Levels From Baseline to 90 Days | 60 days | 16.59 mg/dL | Standard Deviation 0.14 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Transferrin Levels From Baseline to 90 Days | 60 days | 16.69 mg/dL | Standard Deviation 0.16 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Transferrin Levels From Baseline to 90 Days | 30 days | 16.97 mg/dL | Standard Deviation 0.04 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Transferrin Levels From Baseline to 90 Days | Baseline | 17.15 mg/dL | Standard Deviation 0.06 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Serum Transferrin Levels From Baseline to 90 Days | 90 days | 16.47 mg/dL | Standard Deviation 0.12 |
Primary
Change in Total Iron Binding Capacity Levels From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | Baseline | 404.26 mcg/dL | Standard Deviation 1.16 |
| Placebo Only | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 30 days | 401.75 mcg/dL | Standard Deviation 1.07 |
| Placebo Only | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 60 days | 397.21 mcg/dL | Standard Deviation 2.16 |
| Placebo Only | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 90 days | 394.63 mcg/dL | Standard Deviation 2.04 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | Baseline | 401.81 mcg/dL | Standard Deviation 2.12 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 90 days | 393.92 mcg/dL | Standard Deviation 3.17 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 30 days | 399.06 mcg/dL | Standard Deviation 2.19 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 60 days | 396.57 mcg/dL | Standard Deviation 2.62 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 90 days | 386.16 mcg/dL | Standard Deviation 2.3 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 30 days | 391.08 mcg/dL | Standard Deviation 2.06 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 60 days | 388.93 mcg/dL | Standard Deviation 2.09 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | Baseline | 393.06 mcg/dL | Standard Deviation 1.93 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | Baseline | 402.84 mcg/dL | Standard Deviation 1.68 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 30 days | 400.55 mcg/dL | Standard Deviation 1.72 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 90 days | 395.03 mcg/dL | Standard Deviation 1.95 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 60 days | 398.17 mcg/dL | Standard Deviation 1.63 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 90 days | 395.20 mcg/dL | Standard Deviation 1.75 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 60 days | 400.57 mcg/dL | Standard Deviation 1.52 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | 30 days | 407.29 mcg/dL | Standard Deviation 1.61 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Total Iron Binding Capacity Levels From Baseline to 90 Days | Baseline | 411.67 mcg/dL | Standard Deviation 1.53 |
Primary
Change in Transferrin Saturation Factor Levels From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | Baseline | 16.92 % Transferrin | Standard Deviation 0.2 |
| Placebo Only | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 30 days | 17.22 % Transferrin | Standard Deviation 0.23 |
| Placebo Only | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 60 days | 17.69 % Transferrin | Standard Deviation 0.19 |
| Placebo Only | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 90 days | 17.98 % Transferrin | Standard Deviation 0.2 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | Baseline | 17.66 % Transferrin | Standard Deviation 0.24 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 90 days | 19.13 % Transferrin | Standard Deviation 0.42 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 30 days | 18.13 % Transferrin | Standard Deviation 0.32 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 60 days | 18.75 % Transferrin | Standard Deviation 0.38 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 90 days | 20.05 % Transferrin | Standard Deviation 0.3 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 30 days | 18.91 % Transferrin | Standard Deviation 0.23 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 60 days | 19.41 % Transferrin | Standard Deviation 0.27 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | Baseline | 18.49 % Transferrin | Standard Deviation 0.19 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | Baseline | 17.73 % Transferrin | Standard Deviation 0.14 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 30 days | 18.13 % Transferrin | Standard Deviation 0.19 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 90 days | 19.28 % Transferrin | Standard Deviation 0.33 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 60 days | 18.58 % Transferrin | Standard Deviation 0.26 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 90 days | 20.02 % Transferrin | Standard Deviation 0.27 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 60 days | 19.13 % Transferrin | Standard Deviation 0.16 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | 30 days | 18.29 % Transferrin | Standard Deviation 0.13 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Transferrin Saturation Factor Levels From Baseline to 90 Days | Baseline | 17.64 % Transferrin | Standard Deviation 0.1 |
Secondary
Change in Immunoglobulins (IgA) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Immunoglobulins (IgA) From Baseline to 90 Days | Baseline IgA | 200.91 g/dL | Standard Deviation 0.66 |
| Placebo Only | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 30 days IgA | 201.09 g/dL | Standard Deviation 0.98 |
| Placebo Only | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 60 days IgA | 198.97 g/dL | Standard Deviation 1.05 |
| Placebo Only | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 90 days IgA | 196.23 g/dL | Standard Deviation 1.2 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgA) From Baseline to 90 Days | Baseline IgA | 214.75 g/dL | Standard Deviation 1.39 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 90 days IgA | 205.58 g/dL | Standard Deviation 2.75 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 30 days IgA | 212.33 g/dL | Standard Deviation 1.82 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 60 days IgA | 209.24 g/dL | Standard Deviation 2.06 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 90 days IgA | 200.37 g/dL | Standard Deviation 4.67 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 30 days IgA | 207.42 g/dL | Standard Deviation 2.34 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 60 days IgA | 203.48 g/dL | Standard Deviation 4.55 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgA) From Baseline to 90 Days | Baseline IgA | 210.56 g/dL | Standard Deviation 1.26 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgA) From Baseline to 90 Days | Baseline IgA | 204.54 g/dL | Standard Deviation 1.31 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 30 days IgA | 201.29 g/dL | Standard Deviation 2.95 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 90 days IgA | 195.68 g/dL | Standard Deviation 3.22 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 60 days IgA | 198.56 g/dL | Standard Deviation 2.99 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 90 days IgA | 186.22 g/dL | Standard Deviation 3.65 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 60 days IgA | 191.90 g/dL | Standard Deviation 3.65 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgA) From Baseline to 90 Days | 30 days IgA | 194.84 g/dL | Standard Deviation 2.56 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgA) From Baseline to 90 Days | Baseline IgA | 199.97 g/dL | Standard Deviation 1.34 |
Secondary
Change in Immunoglobulins (IgE) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Immunoglobulins (IgE) From Baseline to 90 Days | Baseline IgE | 195.02 IU/mL | Standard Deviation 1.06 |
| Placebo Only | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 30 days IgE | 192.59 IU/mL | Standard Deviation 1.34 |
| Placebo Only | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 60 days IgE | 190.81 IU/mL | Standard Deviation 1.32 |
| Placebo Only | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 90 days IgE | 187.32 IU/mL | Standard Deviation 1.39 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgE) From Baseline to 90 Days | Baseline IgE | 184.86 IU/mL | Standard Deviation 1.14 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 90 days IgE | 176.28 IU/mL | Standard Deviation 3.49 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 30 days IgE | 181.87 IU/mL | Standard Deviation 2.19 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 60 days IgE | 179.00 IU/mL | Standard Deviation 2.63 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 90 days IgE | 174.09 IU/mL | Standard Deviation 3.5 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 30 days IgE | 182.36 IU/mL | Standard Deviation 3.44 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 60 days IgE | 178.23 IU/mL | Standard Deviation 3.79 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgE) From Baseline to 90 Days | Baseline IgE | 186.02 IU/mL | Standard Deviation 2.81 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgE) From Baseline to 90 Days | Baseline IgE | 174.62 IU/mL | Standard Deviation 1.59 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 30 days IgE | 171.73 IU/mL | Standard Deviation 2.63 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 90 days IgE | 164.60 IU/mL | Standard Deviation 3.98 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 60 days IgE | 168.62 IU/mL | Standard Deviation 3.31 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 90 days IgE | 177.73 IU/mL | Standard Deviation 3.9 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 60 days IgE | 185.56 IU/mL | Standard Deviation 2.83 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgE) From Baseline to 90 Days | 30 days IgE | 189.69 IU/mL | Standard Deviation 2.47 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgE) From Baseline to 90 Days | Baseline IgE | 193.76 IU/mL | Standard Deviation 1.49 |
Secondary
Change in Immunoglobulins (IgG) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 60 days IgG | 1678.54 g/dL | Standard Deviation 2.46 |
| Placebo Only | Change in Immunoglobulins (IgG) From Baseline to 90 Days | Baseline IgG | 1684.10 g/dL | Standard Deviation 2.39 |
| Placebo Only | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 90 days IgG | 1674.86 g/dL | Standard Deviation 1.86 |
| Placebo Only | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 30 days IgG | 1681.23 g/dL | Standard Deviation 2.12 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 60 days IgG | 1704.64 g/dL | Standard Deviation 5.8 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 30 days IgG | 1708.98 g/dL | Standard Deviation 5.18 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgG) From Baseline to 90 Days | Baseline IgG | 1718.47 g/dL | Standard Deviation 3.49 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 90 days IgG | 1700.06 g/dL | Standard Deviation 6.47 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 30 days IgG | 1727.20 g/dL | Standard Deviation 3.66 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 90 days IgG | 1711.76 g/dL | Standard Deviation 4.32 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgG) From Baseline to 90 Days | Baseline IgG | 1734.16 g/dL | Standard Deviation 2.61 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 60 days IgG | 1719.79 g/dL | Standard Deviation 4.51 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 30 days IgG | 1687.67 g/dL | Standard Deviation 3.06 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 90 days IgG | 1678.98 g/dL | Standard Deviation 5.66 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 60 days IgG | 1682.53 g/dL | Standard Deviation 4.26 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgG) From Baseline to 90 Days | Baseline IgG | 1691.93 g/dL | Standard Deviation 2.76 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 30 days IgG | 1684.95 g/dL | Standard Deviation 2.32 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 90 days IgG | 1622.73 g/dL | Standard Deviation 2.45 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgG) From Baseline to 90 Days | Baseline IgG | 1707.56 g/dL | Standard Deviation 2.14 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgG) From Baseline to 90 Days | 60 days IgG | 1655.01 g/dL | Standard Deviation 2.39 |
Secondary
Change in Immunoglobulins (IgM) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Immunoglobulins (IgM) From Baseline to 90 Days | Baseline IgM | 303.66 g/dL | Standard Deviation 2.51 |
| Placebo Only | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 30 days IgM | 300.55 g/dL | Standard Deviation 2.51 |
| Placebo Only | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 60 days IgM | 299.38 g/dL | Standard Deviation 2.51 |
| Placebo Only | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 90 days IgM | 296.90 g/dL | Standard Deviation 2.51 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgM) From Baseline to 90 Days | Baseline IgM | 285.20 g/dL | Standard Deviation 2.57 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 90 days IgM | 271.64 g/dL | Standard Deviation 2.93 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 30 days IgM | 281.25 g/dL | Standard Deviation 2.36 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 60 days IgM | 278.21 g/dL | Standard Deviation 2.59 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 90 days IgM | 264.02 g/dL | Standard Deviation 3.15 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 30 days IgM | 271.15 g/dL | Standard Deviation 2.31 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 60 days IgM | 267.81 g/dL | Standard Deviation 2.83 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Immunoglobulins (IgM) From Baseline to 90 Days | Baseline IgM | 273.74 g/dL | Standard Deviation 2.2 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgM) From Baseline to 90 Days | Baseline IgM | 267.76 g/dL | Standard Deviation 3.05 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 30 days IgM | 264.41 g/dL | Standard Deviation 3.05 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 90 days IgM | 256.95 g/dL | Standard Deviation 3.16 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 60 days IgM | 259.83 g/dL | Standard Deviation 3.23 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 90 days IgM | 203.21 g/dL | Standard Deviation 3.43 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 60 days IgM | 213.71 g/dL | Standard Deviation 2.28 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgM) From Baseline to 90 Days | 30 days IgM | 234.41 g/dL | Standard Deviation 1.87 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Immunoglobulins (IgM) From Baseline to 90 Days | Baseline IgM | 256.37 g/dL | Standard Deviation 1.69 |
Secondary
Change in Liver Functions Tests (ALP) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | Baseline ALP | 65.84 IU/L | Standard Deviation 1.54 |
| Placebo Only | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 30 days ALP | 65.63 IU/L | Standard Deviation 2.03 |
| Placebo Only | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 60 days ALP | 65.51 IU/L | Standard Deviation 1.41 |
| Placebo Only | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 90 days ALP | 65.48 IU/L | Standard Deviation 1.38 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | Baseline ALP | 69.35 IU/L | Standard Deviation 0.76 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 90 days ALP | 76.06 IU/L | Standard Deviation 0.71 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 30 days ALP | 71.07 IU/L | Standard Deviation 0.72 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 60 days ALP | 73.34 IU/L | Standard Deviation 0.73 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 90 days ALP | 73.14 IU/L | Standard Deviation 1.35 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 30 days ALP | 73.77 IU/L | Standard Deviation 1.32 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 60 days ALP | 73.42 IU/L | Standard Deviation 1.36 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | Baseline ALP | 73.92 IU/L | Standard Deviation 1.33 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | Baseline ALP | 74.99 IU/L | Standard Deviation 1.25 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 30 days ALP | 74.86 IU/L | Standard Deviation 1.23 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 90 days ALP | 74.55 IU/L | Standard Deviation 1.19 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 60 days ALP | 74.72 IU/L | Standard Deviation 1.24 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 90 days ALP | 68.12 IU/L | Standard Deviation 1.24 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 60 days ALP | 68.19 IU/L | Standard Deviation 1.24 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | 30 days ALP | 68.37 IU/L | Standard Deviation 1.3 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALP) From Baseline to 90 Days | Baseline ALP | 68.43 IU/L | Standard Deviation 1.31 |
Secondary
Change in Liver Functions Tests (ALT) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | Baseline ALT | 10.51 IU/L | Standard Deviation 0.1 |
| Placebo Only | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 30 days ALT | 10.61 IU/L | Standard Deviation 0.23 |
| Placebo Only | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 60 days ALT | 10.59 IU/L | Standard Deviation 0.24 |
| Placebo Only | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 90 days ALT | 11.28 IU/L | Standard Deviation 0.6 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | Baseline ALT | 11.80 IU/L | Standard Deviation 0.18 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 90 days ALT | 10.27 IU/L | Standard Deviation 0.4 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 30 days ALT | 11.10 IU/L | Standard Deviation 0.35 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 60 days ALT | 10.69 IU/L | Standard Deviation 0.4 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 90 days ALT | 11.81 IU/L | Standard Deviation 0.84 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 30 days ALT | 14.31 IU/L | Standard Deviation 0.52 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 60 days ALT | 12.85 IU/L | Standard Deviation 0.76 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | Baseline ALT | 15.18 IU/L | Standard Deviation 0.44 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | Baseline ALT | 14.73 IU/L | Standard Deviation 0.08 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 30 days ALT | 13.24 IU/L | Standard Deviation 0.45 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 90 days ALT | 11.13 IU/L | Standard Deviation 0.89 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 60 days ALT | 12.32 IU/L | Standard Deviation 0.75 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 90 days ALT | 9.27 IU/L | Standard Deviation 0.66 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 60 days ALT | 9.75 IU/L | Standard Deviation 0.7 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | 30 days ALT | 10.54 IU/L | Standard Deviation 0.56 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (ALT) From Baseline to 90 Days | Baseline ALT | 11.59 IU/L | Standard Deviation 0.31 |
Secondary
Change in Liver Functions Tests (AST) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Liver Functions Tests (AST) From Baseline to 90 Days | Baseline AST | 16.83 IU/L | Standard Deviation 0.15 |
| Placebo Only | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 30 days AST | 16.81 IU/L | Standard Deviation 0.14 |
| Placebo Only | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 60 days AST | 16.68 IU/L | Standard Deviation 0.13 |
| Placebo Only | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 90 days AST | 16.55 IU/L | Standard Deviation 0.11 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (AST) From Baseline to 90 Days | Baseline AST | 15.93 IU/L | Standard Deviation 0.53 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 90 days AST | 15.62 IU/L | Standard Deviation 0.56 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 30 days AST | 15.76 IU/L | Standard Deviation 0.54 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 60 days AST | 15.73 IU/L | Standard Deviation 0.55 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 90 days AST | 16.84 IU/L | Standard Deviation 0.25 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 30 days AST | 17.13 IU/L | Standard Deviation 0.19 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 60 days AST | 17.04 IU/L | Standard Deviation 0.22 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (AST) From Baseline to 90 Days | Baseline AST | 18.07 IU/L | Standard Deviation 0.11 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (AST) From Baseline to 90 Days | Baseline AST | 18.77 IU/L | Standard Deviation 0.14 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 30 days AST | 18.90 IU/L | Standard Deviation 0.82 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 90 days AST | 18.78 IU/L | Standard Deviation 0.9 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 60 days AST | 18.80 IU/L | Standard Deviation 0.85 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 90 days AST | 15.75 IU/L | Standard Deviation 0.32 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 60 days AST | 15.87 IU/L | Standard Deviation 0.27 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (AST) From Baseline to 90 Days | 30 days AST | 15.99 IU/L | Standard Deviation 0.21 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (AST) From Baseline to 90 Days | Baseline AST | 16.09 IU/L | Standard Deviation 0.26 |
Secondary
Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | Baseline Total Bilirubin | 0.31 mg/dL | Standard Deviation 0.02 |
| Placebo Only | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 30 days Total Bilirubin | 0.31 mg/dL | Standard Deviation 0.03 |
| Placebo Only | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 60 days Total Bilirubin | 0.26 mg/dL | Standard Deviation 0.04 |
| Placebo Only | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 90 days Total Bilirubin | 0.19 mg/dL | Standard Deviation 0.06 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | Baseline Total Bilirubin | 0.44 mg/dL | Standard Deviation 0.02 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 90 days Total Bilirubin | 0.27 mg/dL | Standard Deviation 0.07 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 30 days Total Bilirubin | 0.41 mg/dL | Standard Deviation 0.03 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 60 days Total Bilirubin | 0.36 mg/dL | Standard Deviation 0.05 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 90 days Total Bilirubin | 0.28 mg/dL | Standard Deviation 0.07 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 30 days Total Bilirubin | 0.43 mg/dL | Standard Deviation 0.03 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 60 days Total Bilirubin | 0.41 mg/dL | Standard Deviation 0.04 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | Baseline Total Bilirubin | 0.47 mg/dL | Standard Deviation 0.02 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | Baseline Total Bilirubin | 0.61 mg/dL | Standard Deviation 0.05 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 30 days Total Bilirubin | 0.55 mg/dL | Standard Deviation 0.07 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 90 days Total Bilirubin | 0.43 mg/dL | Standard Deviation 0.06 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 60 days Total Bilirubin | 0.51 mg/dL | Standard Deviation 0.08 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 90 days Total Bilirubin | 0.11 mg/dL | Standard Deviation 0.03 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 60 days Total Bilirubin | 0.13 mg/dL | Standard Deviation 0.05 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | 30 days Total Bilirubin | 0.20 mg/dL | Standard Deviation 0.04 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days | Baseline Total Bilirubin | 0.35 mg/dL | Standard Deviation 0.03 |
Secondary
Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 60 days Serum Creatinine | 0.78 mg/dL | Standard Deviation 0.03 |
| Placebo Only | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 30 days Serum Creatinine | 0.76 mg/dL | Standard Deviation 0.03 |
| Placebo Only | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 90 days Serum Creatinine | 0.80 mg/dL | Standard Deviation 0.02 |
| Placebo Only | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | Baseline Serum Creatinine | 0.77 mg/dL | Standard Deviation 0.02 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 60 days Serum Creatinine | 0.90 mg/dL | Standard Deviation 0.03 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | Baseline Serum Creatinine | 0.83 mg/dL | Standard Deviation 0.02 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 90 days Serum Creatinine | 0.93 mg/dL | Standard Deviation 0.03 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 30 days Serum Creatinine | 0.86 mg/dL | Standard Deviation 0.03 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 60 days Serum Creatinine | 0.95 mg/dL | Standard Deviation 0.02 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 30 days Serum Creatinine | 0.93 mg/dL | Standard Deviation 0.02 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | Baseline Serum Creatinine | 0.89 mg/dL | Standard Deviation 0.01 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 90 days Serum Creatinine | 0.92 mg/dL | Standard Deviation 0.03 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 30 days Serum Creatinine | 0.70 mg/dL | Standard Deviation 0.04 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | Baseline Serum Creatinine | 0.62 mg/dL | Standard Deviation 0.02 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 60 days Serum Creatinine | 0.77 mg/dL | Standard Deviation 0.05 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 90 days Serum Creatinine | 0.86 mg/dL | Standard Deviation 0.06 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | Baseline Serum Creatinine | 0.65 mg/dL | Standard Deviation 0.02 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 30 days Serum Creatinine | 0.74 mg/dL | Standard Deviation 0.03 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 90 days Serum Creatinine | 0.94 mg/dL | Standard Deviation 0.03 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days | 60 days Serum Creatinine | 0.84 mg/dL | Standard Deviation 0.05 |
Secondary
Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days
Time frame: Baseline, 30 days, 60 days, 90 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Only | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 60 days Serum Urea | 18.23 mg/dL | Standard Deviation 0.21 |
| Placebo Only | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 90 days Serum Urea | 18.01 mg/dL | Standard Deviation 0.1 |
| Placebo Only | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | Baseline Serum Urea | 18.86 mg/dL | Standard Deviation 0.13 |
| Placebo Only | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 30 days Serum Urea | 18.53 mg/dL | Standard Deviation 0.2 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | Baseline Serum Urea | 17.59 mg/dL | Standard Deviation 0.19 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 30 days Serum Urea | 17.77 mg/dL | Standard Deviation 0.18 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 90 days Serum Urea | 17.92 mg/dL | Standard Deviation 0.2 |
| Prebiotic Inulin & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 60 days Serum Urea | 17.86 mg/dL | Standard Deviation 0.17 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | Baseline Serum Urea | 19.60 mg/dL | Standard Deviation 0.33 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 30 days Serum Urea | 19.63 mg/dL | Standard Deviation 0.34 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 60 days Serum Urea | 19.65 mg/dL | Standard Deviation 0.35 |
| Prebiotic GOS & Iron Salt FeSO4 | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 90 days Serum Urea | 19.10 mg/dL | Standard Deviation 2.51 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 30 days Serum Urea | 21.01 mg/dL | Standard Deviation 0.44 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 60 days Serum Urea | 21.06 mg/dL | Standard Deviation 0.47 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | Baseline Serum Urea | 21.02 mg/dL | Standard Deviation 0.46 |
| Prebiotic Inulin & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 90 days Serum Urea | 21.04 mg/dL | Standard Deviation 0.55 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 30 days Serum Urea | 21.56 mg/dL | Standard Deviation 0.29 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 90 days Serum Urea | 21.65 mg/dL | Standard Deviation 0.35 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | 60 days Serum Urea | 21.59 mg/dL | Standard Deviation 0.31 |
| Prebiotic GOS & Iron Salt NaFeEDTA | Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days | Baseline Serum Urea | 21.55 mg/dL | Standard Deviation 0.27 |