Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania ( MMS-MAP ) - MMS vs IFA Trial

Sponsor

George Washington University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06069856

Collaborator

Ifakara Health Institute (Other), Harvard School of Public Health (HSPH) (Other), Muhimbili University of Health and Allied Sciences (Other), Africa Academy for Public Health (Other), Columbia University (Other)

130

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a mixed methods cross-over study to compare acceptability of IFA with 60 mg of iron to MMS with 60 mg of iron. This cross-over study will help contribute evidence to the remaining question about acceptability, preference adherence, and side effects between IFA and MMS (with the same amount of iron). By holding the amount of iron constant, the study can help answer the question about whether the addition of micronutrients affects adherence or acceptability.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related	Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The trial is quadruple blind with all trial participants, outcome assessors (research staff and care providers), investigators, and trials statistician and data analysts being unable to determine the allocated trial arm for any trial participant or identify trial participants who are on the same trial regimen.

Primary Purpose:

Prevention

Official Title:

Individually Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia- MMS Versus IFA Crossover Trial

Anticipated Study Start Date :

Sep 1, 2025

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MMS with 60 mg of iron first, then IFA 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	Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization.
Experimental: IFA with 60 mg of iron first, then MMS 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	Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization.

Arm

Intervention/Treatment

Experimental: MMS with 60 mg of iron first, then IFA 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

Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron

IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization

Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization.

Experimental: IFA with 60 mg of iron first, then MMS 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

Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron

IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization

Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization.

Outcome Measures

Primary Outcome Measures

Acceptability of MMS formulation [Month 1]
To assess acceptability of MMS formulation with 60 mg of iron using Likert scales
Preference of MMS formulation [Month 1]
To assess preference of MMS formulation with 60 mg of iron using questionnaires
Side Effects of MMS formulation [Month 1]
To assess perceived side effects of MMS formulation with 60 mg of iron through questionnaires
Acceptability of MMS formulation [Month 2]
To assess acceptability of MMS formulation with 60 mg of iron using Likert scales
Preference of MMS formulation [Month 2]
To assess preference of MMS formulation with 60 mg of iron using questionnaires
Side Effects of MMS formulation [Month 2]
To assess perceived side effects of MMS formulation with 60 mg of iron using questionnaires
Acceptability of MMS formulation [Month 3]
To assess acceptability of MMS formulation with 60 mg of iron using Likert scales
Preference of MMS formulation [Month 3]
To assess preference of MMS formulation with 60 mg of iron using questionnaires
Side Effects of MMS formulation [Month 3]
To assess perceived side effects of MMS formulation with 60 mg of iron using questionnaires
Acceptability of IFA formulation [Month 1]
To assess acceptability of IFA containing 60 mg of iron using Likert scale
Preference of IFA formulation [Month 1]
To assess preference of IFA containing 60 mg of iron using questionnaires
Side Effects of IFA formulation [Month 1]
To assess perceived side effects of IFA containing 60 mg of iron using questionnaires
Acceptability of IFA formulation [Month 2]
To assess acceptability of IFA containing 60 mg of iron using Likert scale
Preference of IFA formulation [Month 2]
To assess preference of IFA containing 60 mg of iron using questionnaires
Side Effects of IFA formulation [Month 2]
To assess perceived side effects of IFA containing 60 mg of iron using questionnaires
Acceptability of IFA formulation [Month 3]
To assess acceptability of IFA containing 60 mg of iron using Likert scales
Preference of IFA formulation [Month 3]
To assess preference of IFA containing 60 mg of iron using questionnaires
Side Effects of IFA formulation [Month 3]
To assess perceived side effects of IFA containing 60 mg of iron using questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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 (homozygous) as tested by HemoTypeSC
Concurrent participation in other nutritional supplementation trial

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

George Washington University
Ifakara Health Institute
Harvard School of Public Health (HSPH)
Muhimbili University of Health and Allied Sciences
Africa Academy for Public Health
Columbia University

Investigators

Principal Investigator: Blair Wylie, MD, MPH, Columbia University
Principal Investigator: Honorati Masanja, PhD, Ifakara Health Institute
Principal Investigator: Alfa Muhihi, PhD, Africa Academy of Public Health
Principal Investigator: Andrea Pembe, MD, MMed, PhD, FCOG, Muhimbili University of Health and Allied Sciences
Principal Investigator: Emily R Smith, ScD, MPH, The George Washington University
Principal Investigator: Christopher R Sudfeld, ScD, ScM, Harvard University