Status:
RECRUITING
Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial
Lead Sponsor:
George Washington University
Collaborating Sponsors:
Ifakara Health Institute
Harvard School of Public Health (HSPH)
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron.
Eligibility Criteria
Inclusion
- Attending first ANC visit at the study clinic
- 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
- Severe anemia (defined as Hb \<8.5 g/dL per Tanzania standard of care)
- 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.
Key Trial Info
Start Date :
September 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06069869
Start Date
September 26 2025
End Date
March 1 2026
Last Update
October 2 2025
Active Locations (1)
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1
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania