Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status
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
Johns Hopkins Bloomberg School of Public Health
3,200 participants
Aug 25, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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
- Hb ≥70 g/L
- \<20 weeks of gestation based on fetal ultrasound
Exclusion Criteria8
- 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
- Hemoglobin \< 70 g/L
- \<6 weeks of gestation or ≥20 weeks of gestation
- Non-viable or extrauterine pregnancy
- Any contraindications to study supplements
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Interventions
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
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06568315