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Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status
Sponsor: Johns Hopkins Bloomberg School of Public Health
Summary
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.
Official title: Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status: A Randomized Non-inferiority Trial in Burkina Faso and Pakistan
Key Details
Gender
FEMALE
Age Range
15 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3200
Start Date
2025-08-25
Completion Date
2026-08
Last Updated
2025-09-17
Healthy Volunteers
Yes
Conditions
Interventions
Concurrent multiple micronutrient and calcium supplementation
Participants 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
Participants 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
Locations (2)
Institut Africain de Santé Publique (African Institute of Public Health)
Ouagadougou, Burkina Faso
Aga Khan University
Karachi, Pakistan