Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial
NCT ID: NCT06069869
Last Updated: 2025-10-02
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
156 participants
INTERVENTIONAL
2025-09-26
2026-03-31
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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MM 30mg; then MMS 45mg; then MMS 60mg
Participants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month
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 for one month.
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 for one month.
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 for one month.
MM 30mg; then MMS 60mg; then MMS 45mg
Participants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month
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 for one month.
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 for one month.
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 for one month.
MM 45mg; then MMS 30mg; then MMS 60mg
Participants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month
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 for one month.
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 for one month.
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 for one month.
MM 45 mg; then MMS 60mg; then MMS 30mg
Participants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month
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 for one month.
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 for one month.
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 for one month.
MM 60mg; then MMS 30mg; then MMS 45mg
Participants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month
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 for one month.
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 for one month.
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 for one month.
MM 60mg; then MMS 45mg; then MMS 30mg
Participants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month
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 for one month.
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 for one month.
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 for one month.
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 for one month.
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 for one month.
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 for one month.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 for Public Health
Andreas 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
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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Other Identifiers
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MID-ACT
Identifier Type: -
Identifier Source: org_study_id
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