RecruitingPhase 3NCT06568315

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


Sponsor

Johns Hopkins Bloomberg School of Public Health

Enrollment

3,200 participants

Start Date

Aug 25, 2025

Study Type

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

Sex: FEMALEMin Age: 15 Years

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

DIETARY_SUPPLEMENTConcurrent 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

DIETARY_SUPPLEMENTSeparate 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

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NCT06568315


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