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

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

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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency
• Intervention / Treatment: Combination product: Prebiotic + Iron Forificant

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).

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • University of Veterinary and Animal Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Investigators: Study Director: Dr. Waqas Ahmad, PhD, University of Veterinary & Animal Sciences, Lahore, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2019
• Primary Completion (Actual): July 6, 2019
• Study Completion (Actual): July 6, 2019

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency
• Other Study ID Numbers: 2015-VA-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We will see what and how much data will we able to ethically share later on.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No