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RECRUITING
NCT06568315
PHASE3

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

Sponsor: Johns Hopkins Bloomberg School of Public Health

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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