About this trial
The World Health Organization (WHO) currently recommends the pregnant women receive iron-containing supplements and, in settings where calcium intake is low, calcium supplements. Supplements are to be taken at two separate times of the day as calcium may interfere with iron absorption. The goal of this clinical trial is to learn whether taking daily calcium supplements and iron-containing multiple micronutrient supplements together, at the same time, has any negative impact on the hemoglobin or iron status of pregnant women or the woman's infants. Participants will be randomly assigned and counseled to either take the supplements together every morning or to take the multiple micronutrient supplement in the morning and the calcium supplement in the evening. Participants will visit the antenatal clinic monthly and be asked to provide a blood sample in early, mid, and late pregnancy. Researchers will also take blood samples from infants at the time of birth.
Eligibility criteria
Qualifiers
Burkina Faso: married or unmarried pregnant women aged ≥15 years
Pakistan: married pregnant women ≥18 years
Willing to receive all antenatal care at a study clinic
Willing to stop iron folic acid supplementation to receive the study intervention
Disqualifiers
Burkina Faso: <15 years or unmarried pregnant women <18 years without consent from parent / guardian
Pakistan: pregnant women <18 years.
Unwilling to receive antenatal care at a study clinic
Unwilling to stop iron folic acid supplementation to receive the study intervention
Trial design
Treatments tested in this trial
- Concurrent multiple micronutrient and calcium supplementation
- Separate multiple micronutrient and calcium supplementation
Treatment groups
Sponsors and collaborators
Johns Hopkins Bloomberg School of Public Health
Lead sponsor
Institut Africain de Santé Publique (African Institute of Public Health)
Collaborator
Aga Khan University
Collaborator
Bill and Melinda Gates Foundation
Collaborator
Children's Investment Fund Foundation
Collaborator