drugset / Trial / NCT03894449

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

NCT03894449

RandomizedFactorialDouble-blindTreatment

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.

Timeline

Start
2019-04-06
Primary completion
2019-07-06
Completion
2019-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferrous Sulfate Diagnostic / imaging agent
Subject GOS Unknown
Subject Inulin Other / unclassified
Subject NaFeEDTA Unknown