Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania ( MMS-MAP )- MMS Iron Dose Trial

Sponsor

George Washington University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06069869

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)

156

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a mixed methods cross-over study to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron. The use of a cross-over design is used in studies examining the acceptability of other nutritional products, including Ready-to-Use Therapeutic Foods.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related	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	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Each participant will be randomized to one of 6 sequence orders to receive the three MMS regimens first, second or third in order (e.g., 30, 45, then 60 mg; or 45, 30, then 60 mg; or 45, 60 then 30 mg etc.).Each participant will be randomized to one of 6 sequence orders to receive the three MMS regimens first, second or third in order (e.g., 30, 45, then 60 mg; or 45, 30, then 60 mg; or 45, 60 then 30 mg etc.).

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 Iron Dose 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 30 mg iron first, then MMS with 45 mg of iron, then MMS wit 60 mg of iron	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization to end of study. Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization to end of study. 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 to end of study.
Experimental: MMS with 30 mg iron first, then MMS with 60 mg of iron, then MMS with 45 mg of iron	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization to end of study. Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization to end of study. 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 to end of study.
Experimental: MMS with 45 mg iron first, then MMS with 30 mg of iron, then MMS with 60 mg of iron	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization to end of study. Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization to end of study. 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 to end of study.
Experimental: MMS with 45 mg first, then MMS with 60 mg of iron, then MMS with 45 mg of iron	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization to end of study. Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization to end of study. 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 to end of study.
Experimental: MMS with 60 mg of iron first, then MMS with 30 mg of iron, then MMS with 45 mg of iron	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization to end of study. Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization to end of study. 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 to end of study.
Experimental: MMS with 60 mg of iron first, then MMS with 45 mg of iron, then MMS with 30 mg of iron	Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization to end of study. Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization to end of study. 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 to end of study.

Outcome Measures

Primary Outcome Measures

Acceptability of MMS formulations [Month 1]
To assess acceptability of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using Likert scales
Preference of MMS formulations [Month 1]
To assess preference of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
Side effects of MMS formulations [Month 1]
To assess perceived side effects of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
Acceptability of MMS formulations [Month 2]
To assess acceptability of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using Likert scales
Preference of MMS formulations [Month 2]
To assess preference of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
Side effects of MMS formulations [Month 2]
To assess perceived side effects of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
Acceptability of MMS formulations [Month 3]
To assess acceptability of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using Likert scales
Preference of MMS formulations [Month 3]
To assess preference of MMS formulations with 30 mg, 45 mg, and 60 mg of iron using questionnaires
Side effects of MMS formulations [Month 3]
To assess perceived side effects of MMS formulations with 30 mg, 45 mg, and 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 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 (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 for Public Health
Principal Investigator: Andreas 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