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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 15
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Burkina Faso
Institut Africain de Santé Publique (African Institute of Public Health)
RECRUITING
Ouagadougou
Pakistan
Aga Khan University
RECRUITING
Karachi
Contact Information
Primary
Amanda C Palmer, PhD
acpalmer@jhu.edu
1 (410) 955-2061
Backup
Monica Pasqualino, PhD
mpasqua2@jhmi.edu
Time Frame
Start Date: 2025-08-25
Estimated Completion Date: 2026-08
Participants
Target number of participants: 3200
Treatments
Experimental: Concurrent MMS / Calcium
Daily multiple micronutrient supplement (providing 30 mg iron) taken concurrently with daily calcium supplement (500 mg)
Active_comparator: Separate MMS / Calcium
Daily multiple micronutrient supplement (providing 30 mg iron) taken separately from daily calcium supplement (500 mg)
Related Therapeutic Areas
Sponsors
Collaborators: Bill and Melinda Gates Foundation, Institut Africain de Santé Publique (African Institute of Public Health), Aga Khan University, Children's Investment Fund Foundation
Leads: Johns Hopkins Bloomberg School of Public Health

This content was sourced from clinicaltrials.gov