Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial

Phase 3

Not yet recruiting

• Conditions: Pregnancy Related
• Interventions: Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

• 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: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Study Start: 2025-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_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 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
MM 30mg; then MMS 45mg; then MMS 60mg	Multiple Micronutrient Supplements with 30 mg of elemental iron	Participants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month
MM 30mg; then MMS 60mg; then MMS 45mg	Multiple Micronutrient Supplements with 45 mg of elemental iron	Participants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month
MM 45mg; then MMS 30mg; then MMS 60mg	Multiple Micronutrient Supplements with 60 mg of elemental iron	Participants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month
MM 30mg; then MMS 45mg; then MMS 60mg	Multiple Micronutrient Supplements with 45 mg of elemental iron	Participants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month
MM 30mg; then MMS 60mg; then MMS 45mg	Multiple Micronutrient Supplements with 60 mg of elemental iron	Participants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month
MM 30mg; then MMS 45mg; then MMS 60mg	Multiple Micronutrient Supplements with 60 mg of elemental iron	Participants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month
MM 30mg; then MMS 60mg; then MMS 45mg	Multiple Micronutrient Supplements with 30 mg of elemental iron	Participants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month
MM 45mg; then MMS 30mg; then MMS 60mg	Multiple Micronutrient Supplements with 30 mg of elemental iron	Participants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month
MM 45mg; then MMS 30mg; then MMS 60mg	Multiple Micronutrient Supplements with 45 mg of elemental iron	Participants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month
MM 45 mg; then MMS 60mg; then MMS 30mg	Multiple Micronutrient Supplements with 60 mg of elemental iron	Participants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month
MM 60mg; then MMS 30mg; then MMS 45mg	Multiple Micronutrient Supplements with 30 mg of elemental iron	Participants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month
MM 60mg; then MMS 30mg; then MMS 45mg	Multiple Micronutrient Supplements with 45 mg of elemental iron	Participants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month
MM 60mg; then MMS 45mg; then MMS 30mg	Multiple Micronutrient Supplements with 30 mg of elemental iron	Participants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month
MM 45 mg; then MMS 60mg; then MMS 30mg	Multiple Micronutrient Supplements with 30 mg of elemental iron	Participants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month
MM 45 mg; then MMS 60mg; then MMS 30mg	Multiple Micronutrient Supplements with 45 mg of elemental iron	Participants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month
MM 60mg; then MMS 30mg; then MMS 45mg	Multiple Micronutrient Supplements with 60 mg of elemental iron	Participants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month
MM 60mg; then MMS 45mg; then MMS 30mg	Multiple Micronutrient Supplements with 45 mg of elemental iron	Participants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month
MM 60mg; then MMS 45mg; then MMS 30mg	Multiple Micronutrient Supplements with 60 mg of elemental iron	Participants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month

Primary Outcome Measures

Name	Time	Method
Acceptability of MMS formulations	At one month of taking each regimen	To assess acceptability of MMS formulations with 30 mg, 45 mg, and 60 mg of iron 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)	To assess participated reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking which supplement participant likes the best.
Adherence	At one month of taking each regimen	Percentage pill count of the number of supplements taken
Side effects of MMS formulations	At one month At one month of taking each regimen	To assess the percentage of patients experiencing side effects of MMS formulations with 30 mg, 45 mg, and 60 mg of iron