Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status

Recruiting now · Phase 3

Conditions studied: Anemia, Iron Deficiency

In brief

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.

Key facts

Study ID

NCT06568315

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

3200

Starts

2025-08-25

Expected to finish

2027-04-01

Last updated by the study team

2026-08-10

Who can join

Age: 15 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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
• 6<20 weeks of gestation based on fetal ultrasound

You may not qualify if…

• 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

Where it is running

• Institut Africain de Santé Publique (African Institute of Public Health) — Ouagadougou, Burkina Faso (enrolling)
• Aga Khan University — Karachi, Pakistan (enrolling)

Full record on ClinicalTrials.gov

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