Actively Recruiting
Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status
Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2025-09-17
3200
Participants Needed
2
Research Sites
48 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins Bloomberg School of Public Health
Lead Sponsor
I
Institut Africain de Santé Publique (African Institute of Public Health)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women in Burkina Faso aged 15 years or older, married or unmarried
- Pregnant married women in Pakistan aged 18 years or older
- Willing to receive all antenatal care at a study clinic
- Willing to stop iron folic acid supplements to take the study supplements
- Hemoglobin measurement of 70 g/L or higher
- Pregnancy between greater than 6 weeks and less than 20 weeks by fetal ultrasound
You will not qualify if you...
- Pregnant women in Burkina Faso younger than 15 years or unmarried pregnant women younger than 18 years without parental or guardian consent
- Pregnant women in Pakistan younger than 18 years
- Unwilling to receive antenatal care at a study clinic
- Unwilling to stop iron folic acid supplements to take the study supplements
- Hemoglobin less than 70 g/L
- Pregnancy less than 6 weeks or 20 weeks or more
- Non-viable or ectopic pregnancy
- Any medical conditions that make study supplements unsafe
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Institut Africain de Santé Publique (African Institute of Public Health)
Ouagadougou, Burkina Faso
Actively Recruiting
2
Aga Khan University
Karachi, Pakistan
Actively Recruiting
Research Team
A
Amanda C Palmer, PhD
CONTACT
M
Monica Pasqualino, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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