Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial
ConditionPregnancy Related
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGeorge Washington University
About this trial
This is an open-label individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.
Eligibility criteria
Qualifiers
Attending first ANC visit at the study clinic
Pregnant women ≤ 15 weeks of gestation
Aged ≥ 18 years
Intending to stay in the study area for the duration of study
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Iron Folic Acid Tablets with 60 mg of iron
- Multiple Micronutrient Supplements with 60 mg of elemental iron
Treatment groups
130 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
George Washington University
Lead sponsor
Ifakara Health Institute
Collaborator
Harvard School of Public Health (HSPH)
Collaborator
Muhimbili University of Health and Allied Sciences
Collaborator
Africa Academy for Public Health
Collaborator
Columbia University
Collaborator
Source ClinicalTrials.gov