Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial

Phase 3

Not yet recruiting

• Conditions: Pregnancy Related
• Interventions: Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

• 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: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Study Start: 2025-06
• Primary Completion: 2026-07
• Study Completion: 2026-07

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 and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
• Concurrent participation in other nutritional supplementation trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MMS with 60 mg of iron first, then IFA with 60 mg of iron	Iron Folic Acid Tablets with 60 mg of iron	Women will receive the first regimen (MMS with 60 mg of iron) for 2 months and then crossover on to the second regimen (IFA with 60 mg of iron) for 2 months
MMS with 60 mg of iron first, then IFA with 60 mg of iron	Multiple Micronutrient Supplements with 60 mg of elemental iron	Women will receive the first regimen (MMS with 60 mg of iron) for 2 months and then crossover on to the second regimen (IFA with 60 mg of iron) for 2 months
IFA with 60 mg of iron first, then MMS with 60 mg of iron	Multiple Micronutrient Supplements with 60 mg of elemental iron	Women will receive the first regimen (IFA with 60 mg of iron) for 2 months and then crossover on to the second regimen (MMS with 60 mg of iron) for 2 months
IFA with 60 mg of iron first, then MMS with 60 mg of iron	Iron Folic Acid Tablets with 60 mg of iron	Women will receive the first regimen (IFA with 60 mg of iron) for 2 months and then crossover on to the second regimen (MMS with 60 mg of iron) for 2 months

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