Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

NCT06079918 | Recruiting Phase 3 DMC

• 1 other identifier: MMS-MAP
• Study Type: interventional
• Target: 6,381
• Locations: 1 country
• Sites: 1

Brief Summary

This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.

Conditions

Pregnancy Related

Keywords

Pregnancy; Multiple Micronutrient Supplementation; Iron; Anemia; Tanzania

Outcome Measures

Primary Outcomes (1)

• Proportion of pregnant women with third-trimester moderate or severe anemia

  Defined as a hemoglobin concentration \<10 g/dL.

  3rd trimester (weeks 28-42 of pregnancy)

Secondary Outcomes (31)

• Maternal hemoglobin concentration

  3rd trimester (weeks 28-42 of pregnancy)

• Maternal hemoglobin concentration

  6 weeks postpartum

• Proportion of pregnant women with anemia

  3rd trimester (weeks 28-42 of pregnancy)

• Proportion of postpartum women with anemia

  6 weeks postpartum

• Maternal serum ferritin

  3rd trimester (weeks 28-42 of pregnancy)

Other Outcomes (10)

• Percent adherence

  During pregnancy (up to week 42)

• Diarrhea

  During pregnancy (up to week 42)

• Heartburn

  During pregnancy (up to week 42)

Study Arms (3)

MMS with 30 mg iron

ACTIVE COMPARATOR

MMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron

Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron

MMS with 45 mg iron

EXPERIMENTAL

MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients

Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron

MMS with 60 mg iron

EXPERIMENTAL

MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients

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

Interventions

Multiple Micronutrient Supplements with 30 mg of elemental iron DIETARY_SUPPLEMENT

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 until delivery.

MMS with 30 mg iron

Multiple Micronutrient Supplements with 45 mg of elemental iron DIETARY_SUPPLEMENT

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 until delivery.

MMS with 45 mg iron

Multiple Micronutrient Supplements with 60 mg of elemental iron DIETARY_SUPPLEMENT

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 until delivery.

MMS with 60 mg iron

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Attending first ANC visit at study clinics
• Pregnant women \< 20 weeks gestation by last menstrual period (LMP)
• Aged ≥ 18 years old
• Intending to stay in Dar es Salaam until 6 weeks post delivery
• Provides informed consent

You may not qualify if:

• Severe anemia (defined as hemoglobin \< 8.5 g/dL per Tanzania standard of care)
• Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
• Concurrently enrolled in another nutritional clinical trial
• Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.

Sponsors & Collaborators

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

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

RECRUITING

Related Publications (1)

• Smith ER, Muhihi A, Wylie BJ, Mugusi S, Aboud S, Bakari M, Fawzi W, Kinyogoli S, Oakley EM, Pan Q, Sando MM, Brownlee VS, Pembe AB, Sudfeld CR, Masanja H. Multiple micronutrient supplementation for maternal anemia prevention (MMS-MAP): an individually randomized trial of higher-dose iron (60 mg, 45 mg) compared to low-dose iron (30 mg) in multiple micronutrient supplements in pregnancy. Trials. 2025 Jun 14;26(1):206. doi: 10.1186/s13063-025-08906-7.

  PMID: 40517226 DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Blair Wylie, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Honorati Masanja, PhD

  Ifakara Health Institute

  PRINCIPAL INVESTIGATOR

• Alfa Muhihi, MD, MPH

  Africa Academy for 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 Goerge Washington University

  PRINCIPAL INVESTIGATOR

• Christopher R Sudfeld, ScD, ScM

  Harvard University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily R Smith, ScD, MPH

CONTACT

202-994-3589; emilysmith@gwu.edu

Christopher R Sudfeld, ScD, ScM

CONTACT

csudfeld@hsph.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: October 12, 2023
• Study Start: March 3, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

TA (1)