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.
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
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
Parallel
Concurrent multiple micronutrient and calcium supplementation
Dietary supplementParticipants counseled to take United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) multiple micronutrient supplement providing 30 mg elemental iron and calcium supplement providing 500 mg elemental calcium as 1250 mg calcium carbonate together every morning from enrollment through the end of pregnancy
Separate multiple micronutrient and calcium supplementation
Dietary supplementParticipants counseled to take United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) multiple micronutrient supplement (MMS) providing 30 mg elemental iron every morning and calcium supplement providing 500 mg elemental calcium as 1250 mg calcium carbonate every evening from enrollment through the end of pregnancy
Hemoglobin concentration of pregnant women
Hemoglobin measured by hematology analyzer
Ferritin concentration
Ferritin (μg/L)
Soluble transferrin receptor (sTfR) concentration
sTfR (mg/L)
Hepcidin concentration
Hepcidin (ng/mL)
Erythropoietin (EPO) concentration
EPO (mIU/mL)
Proportion of women with anemia
Hemoglobin \< 110 g/L
Proportion of women with severe anemia (intervention safety)
Hemoglobin \< 70 g/L
Proportion of women with iron deficiency
Ferritin \<15 μg/L (adjusted for inflammation)
Proportion of women with iron-deficient erythropoiesis
Elevated sTfR concentration
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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