Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGeorge Washington University

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

6,381 Participants
are divided into 3 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