Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial
NCT ID: NCT06069856
Last Updated: 2025-06-24
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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NOT_YET_RECRUITING
PHASE3
130 participants
INTERVENTIONAL
2026-01-31
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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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
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
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.
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
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
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Sickle cell disease (SS,SC, CC genotype) as tested by HemoTypeSC
* Concurrent participation in other nutritional supplementation 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, PhD
Role: PRINCIPAL_INVESTIGATOR
Africa Academy of 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 George Washington University
Christopher R Sudfeld, ScD, ScM
Role: PRINCIPAL_INVESTIGATOR
Harvard University
Central Contacts
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Other Identifiers
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MIFA-ACT
Identifier Type: -
Identifier Source: org_study_id
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