Phase 2
Completed N=75
Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic Subjects
Source: ClinicalTrials.gov NCT03894449 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Change in Hemoglobin Concentration From Baseline to 90 Days — 11.44; 11.58; 11.54; 11.61 g/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin Concentration From Baseline to 90 Days |
11.44; 11.58; 11.54; 11.61; 11.28; 11.52 | — |
| PRIMARY Change in Hematocrit in Concentration From Baseline to 90 Days |
30.26; 33.76; 32.77; 33.50; 31.50; 31.62 | — |
| PRIMARY Change in Mean Corpuscular Volume From Baseline to 90 Days |
68.53; 69.56; 73.79; 76.61; 78.06; 70.46 | — |
| PRIMARY Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days |
21.94; 23.63; 20.63; 24.02; 24.56; 23.24 | — |
| PRIMARY Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days |
31.44; 29.30; 28.06; 29.05; 28.51; 31.07 | — |
| PRIMARY Change in Serum Iron Levels From Baseline to 90 Days |
68.41; 70.97; 72.65; 71.41; 72.60; 69.17 | — |
| PRIMARY Change in Serum Folate Levels From Baseline to 90 Days |
8.74; 9.26; 8.05; 8.96; 8.20; 8.81 | — |
| PRIMARY Change in Serum Ferritin Levels From Baseline to 90 Days |
11.76; 13.73; 13.29; 12.03; 12.67; 11.86 | — |
| PRIMARY Change in Serum Transferrin Levels From Baseline to 90 Days |
16.84; 16.74; 16.38; 16.79; 17.15; 16.74 | — |
| PRIMARY Change in Transferrin Saturation Factor Levels From Baseline to 90 Days |
16.92; 17.66; 18.49; 17.73; 17.64; 17.22 | — |
| PRIMARY Change in Total Iron Binding Capacity Levels From Baseline to 90 Days |
404.26; 401.81; 393.06; 402.84; 411.67; 401.75 | — |
| SECONDARY Change in Liver Functions Tests (ALT) From Baseline to 90 Days |
10.51; 11.80; 15.18; 14.73; 11.59; 10.61 | — |
| SECONDARY Change in Liver Functions Tests (AST) From Baseline to 90 Days |
16.83; 15.93; 18.07; 18.77; 16.09; 16.81 | — |
| SECONDARY Change in Liver Functions Tests (ALP) From Baseline to 90 Days |
65.84; 69.35; 73.92; 74.99; 68.43; 65.63 | — |
| SECONDARY Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days |
0.31; 0.44; 0.47; 0.61; 0.35; 0.31 | — |
| SECONDARY Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days |
18.86; 17.59; 19.60; 21.02; 21.55; 18.53 | — |
| SECONDARY Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days |
0.77; 0.83; 0.89; 0.62; 0.65; 0.76 | — |
| SECONDARY Change in Immunoglobulins (IgA) From Baseline to 90 Days |
200.91; 214.75; 210.56; 204.54; 199.97; 201.09 | — |
| SECONDARY Change in Immunoglobulins (IgE) From Baseline to 90 Days |
195.02; 184.86; 186.02; 174.62; 193.76; 192.59 | — |
| SECONDARY Change in Immunoglobulins (IgG) From Baseline to 90 Days |
1684.10; 1718.47; 1734.16; 1691.93; 1707.56; 1681.23 | — |
| SECONDARY Change in Immunoglobulins (IgM) From Baseline to 90 Days |
303.66; 285.20; 273.74; 267.76; 256.37; 300.55 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03894449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.