Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
NCT ID: NCT06079918
Last Updated: 2025-07-01
Study Results
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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RECRUITING
PHASE3
6381 participants
INTERVENTIONAL
2025-03-03
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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MMS with 30 mg iron
MMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron
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.
MMS with 45 mg iron
MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
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.
MMS with 60 mg iron
MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
Yes
Sponsors
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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
George Washington University
OTHER
Responsible Party
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Emily Smith
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
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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MMS-MAP
Identifier Type: -
Identifier Source: org_study_id
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