MedTrace Logo

Fermented Iron-rich Supplement in Reducing Anemia

NCT02037724 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-01-16

No results posted yet for this study

Summary

The consequences of iron deficiency anemia in women are enormous, and especially in developing countries, as the condition adversely affects both their productive and reproductive capabilities. The study seeks to: 1) compare changes in iron status indicators among women receiving an iron-rich organic food supplement versus ferrous sulfate supplement, and 2) determine the suitable level of food supplement needed to prevent/reduce iron deficiency anemia among women in developing country settings.

A double-blind, randomized, controlled, intervention trial will be implemented in women of childbearing age, 60 women with iron deficiency anemia and 60 women with iron deficiency. After screening potential subjects (up to 500 expected), approximately 30 will be recruited into each of four study groups; assuming 30% dropout rate, to detect an increase of 30% in ferritin as significant between the two time points at 80% power and alpha value of 0.05. Subjects who meet the inclusion criteria will be randomized into the four groups consisting of: 2 control groups (daily 60mg ferrous sulfate (FS-60) or daily 10mg ferrous sulfate (FS-10)), and 2 test groups (daily 60mg iron-rich supplement (IRS-60) or 10mg iron-rich supplement (IRS-10)). Subjects will take daily FS-60 and IRS-60 under supervision for 8 weeks while subjects taking FS-10 and IRS-10 will take the supplement under supervision for 12 consecutive weeks.

Conditions

Interventions

DIETARY_SUPPLEMENT

supplement containing 60 mg iron sulfate

control agent

DIETARY_SUPPLEMENT

iron rich food supplement (60 mg iron)

contains 60 mg of iron

DIETARY_SUPPLEMENT

iron rich food supplement (10 mg iron)

contains 10 mg iron

DIETARY_SUPPLEMENT

supplement containing 10 mg iron sulfate

control agent

Sponsors & Collaborators

  • University of Ghana

    lead OTHER

Principal Investigators

  • Richmond Aryeetey, PhD · University of Ghana

  • Manju Reddy, PhD · Iowa State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-08-31
Completion
2014-10-31

More Related Trials

Entities

Diseases

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 NCT02037724 on ClinicalTrials.gov