Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial

Phase 3

Recruiting

• Conditions: Pregnancy Related

• Registration Number: NCT06069869
• Lead Sponsor: George Washington University

Brief Summary

This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 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: 2025-09
• Study Start: 2025-09-26
• Last Update Submitted: 2025-09-28
• Last Update Posted: 2025-10-02
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 156

Inclusion Criteria

• Attending first ANC visit at the study clinic
• Pregnant women ≤ 15 weeks of gestation
• Aged ≥ 18 years
• Intending to stay in Dar es Salaam 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 MMS formulations	At one month of taking each regimen	Participant reported acceptability of each MMS formulation using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).

Secondary Outcome Measures

Name	Time	Method
Most preferred MMS formulation	At three months (after taking all three regimens)	Participant's reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking which supplement participant likes the best.
Least preferred MMS formulation	At three months (after taking all three regimens)	Participant's reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking which supplement participant likes the least.
Identification of MMS iron dosage	At three months (after taking all three regimens)	Percentage of participants that correctly identify their iron dose treatment order
Side effects of MMS formulations	At one month of taking each regimen	The percentage of patients experiencing any side effect (diarrhea, heartburn, constipation, vomiting, nausea, leg cramps, lower back/pelvic pain) during each intervention period
Adherence	At one month of taking each regimen	The percentage of days a participant takes a MMS pill out of the total number of days in the intervention period

Trial Locations

Locations (1)

Muhimbili University of Health and Allied Sciences; 🇹🇿 Dar es Salaam, Tanzania