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

NCT03894449 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-08-22

Study results available
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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.

Conditions

  • Iron-deficiency

Interventions

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.

Sponsors & Collaborators

  • University of Veterinary and Animal Sciences, Lahore - Pakistan

    lead OTHER

Principal Investigators

  • Dr. Waqas Ahmad, PhD · University of Veterinary & Animal Sciences, Lahore, Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03894449 on ClinicalTrials.gov