About this trial
This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.
Eligibility criteria
Qualifiers
Attending first ANC visit at study clinics
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
Disqualifiers
Severe anemia (defined as hemoglobin < 8.5 g/dL per Tanzania standard of care)
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.
Trial design
Treatments tested in this trial
- Multiple Micronutrient Supplements with 30 mg of elemental iron
- Multiple Micronutrient Supplements with 45 mg of elemental iron
- Multiple Micronutrient Supplements with 60 mg of elemental iron
Treatment groups
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