Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic Subjects

Study Overview
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Brief Summary
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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
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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).

Official Title
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Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic

Conditions
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Iron-deficiency

Intervention / Treatment
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* Combination Product: Prebiotic + Iron Forificant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo only<br> | Combination Product: Prebiotic + Iron Forificant<br>* A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.<br>|
| Experimental: Prebiotic Inulin & Iron Salt FeSO4<br> | Combination Product: Prebiotic + Iron Forificant<br>* A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.<br>|
| Experimental: Prebiotic GOS & Iron Salt FeSO4<br> | Combination Product: Prebiotic + Iron Forificant<br>* A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.<br>|
| Experimental: Prebiotic Inulin & Iron Salt NaFeEDTA<br> | Combination Product: Prebiotic + Iron Forificant<br>* A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.<br>|
| Experimental: Prebiotic GOS & Iron Salt NaFeEDTA<br> | Combination Product: Prebiotic + Iron Forificant<br>* A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in Total Iron Binding Capacity Levels From Baseline to 90 Days |  | Baseline, 30 days, 60 days, 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 Immunoglobulins (IgE) From Baseline to 90 Days |  | Baseline, 30 days, 60 days, 90 days | 
| 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 |