Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial

Phase 3

Not yet recruiting

• Conditions: Pregnancy Related

• Registration Number: NCT06069856
• Lead Sponsor: George Washington University

Brief Summary

This is an individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-29
• Study First Posted: 2023-10-06
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24
• Study Start: 2026-01-01
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• Attending first ANC visit at the study clinic
• Pregnant women ≤ 15 weeks of gestation
• Aged ≥ 18 years
• Intending to stay in the study area for the duration of study
• Provides informed consent

Exclusion Criteria

• Severe anemia (defined as Hb <8.5 g/dL per Tanzania standard of care)
• Sickle cell disease (SS,SC, CC genotype) as tested by HemoTypeSC
• Concurrent participation in other nutritional supplementation trial
• Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Acceptability of formulation	At two months of taking each regimen	To assess acceptability of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).

Secondary Outcome Measures

Name	Time	Method
Adherence	At two months of taking each regimen	Percentage pill count of the number of supplements taken
Most preferred formulation	At four months (after taking both regimens)	To assess participated reported preference of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron by asking participants which supplement they like the best.
Side Effects of formulation	At two months of taking each regimen	To assess the percentage of patients experiencing side effects of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron