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

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.

Conditions

• Anemia, Iron Deficiency

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

Sponsors & Collaborators

• Institut Africain de Santé Publique (African Institute of Public Health)

  collaborator UNKNOWN

• Aga Khan University

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Children's Investment Fund Foundation

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Amanda Palmer, PhD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-08-25

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• Burkina Faso
• Pakistan

Study Locations