Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

NCT ID: NCT06079918

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

6381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-03

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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MMS with 30 mg iron

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

Group Type ACTIVE_COMPARATOR

Multiple Micronutrient Supplements with 30 mg of elemental iron

Intervention Type 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 45 mg iron

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

Group Type EXPERIMENTAL

Multiple Micronutrient Supplements with 45 mg of elemental iron

Intervention Type 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 60 mg iron

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

Group Type EXPERIMENTAL

Multiple Micronutrient Supplements with 60 mg of elemental iron

Intervention Type 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.

Interventions

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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 until delivery.

Intervention Type 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 until delivery.

Intervention Type 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 until delivery.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ifakara Health Institute

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

Africa Academy for Public Health

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

George Washington University

OTHER

Sponsor Role lead

Responsible Party

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Emily Smith

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Blair Wylie, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Honorati Masanja, PhD

Role: PRINCIPAL_INVESTIGATOR

Ifakara Health Institute

Alfa Muhihi, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Africa Academy for Public Health

Andrea Pembe, MD, MMed, PhD, FCOG

Role: PRINCIPAL_INVESTIGATOR

Muhimbili University of Health and Allied Sciences

Emily R Smith, ScD, MPH

Role: PRINCIPAL_INVESTIGATOR

The Goerge Washington University

Christopher R Sudfeld, ScD, ScM

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Locations

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Muhimbili University of Health and Allied Sciences

Dar es Salaam, , Tanzania

Site Status RECRUITING

Countries

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Tanzania

Central Contacts

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Emily R Smith, ScD, MPH

Role: CONTACT

202-994-3589

Christopher R Sudfeld, ScD, ScM

Role: CONTACT

Facility Contacts

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Andrea Pembe, MD

Role: primary

255-754-262-483

References

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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.

Reference Type DERIVED
PMID: 40517226 (View on PubMed)

Other Identifiers

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MMS-MAP

Identifier Type: -

Identifier Source: org_study_id

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