Actively Recruiting
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
Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2025-09-17
3200
Participants Needed
2
Research Sites
N/A
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
Pregnant women in low-and-middle-income countries often face micronutrient deficiencies worsened by pregnancy demands. This trial evaluates whether taking daily calcium supplements and iron-containing multiple micronutrient supplements together affects the hemoglobin and iron status of pregnant women and their infants. The goal is to determine if co-administration impacts these measures compared to taking the supplements separately, addressing adherence challenges and potential development of a combined supplement. The study involves 1,600 pregnant women in Burkina Faso and Pakistan who will be randomly assigned to one of two groups: one taking both supplements together every morning, and the other taking the multiple micronutrient supplement in the morning and calcium in the evening. The calcium supplement provides 500 mg elemental calcium, and the multiple micronutrient supplement contains 30 mg elemental iron. Participants will receive counseling and monthly antenatal clinic visits throughout pregnancy. Participants will provide blood samples early, mid, and late in pregnancy to assess hemoglobin and iron status. Infant blood samples will be collected within 72 hours of birth. Researchers will track supplement adherence, side effects, anemia symptoms, and any additional iron treatments. The primary outcome is hemoglobin concentration at 30 to less than 34 weeks gestation, with several secondary measures related to iron status also evaluated. The study will continue until August 2026.
CONDITIONS
Brief 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...
- Burkina Faso: married or unmarried pregnant women aged 15 years or older
- Pakistan: married pregnant women aged 18 years or older
- Willingness to receive all antenatal care at a study clinic
- Willingness to stop iron folic acid supplementation to receive the study intervention
- Hemoglobin level 70 g/L or higher
- Pregnancy between 6 and 20 weeks gestation confirmed by fetal ultrasound
You will not qualify if you...
- Burkina Faso: pregnant women younger than 15 years or unmarried pregnant women younger than 18 years without parental or guardian consent
- Pakistan: pregnant women younger than 18 years
- Unwillingness to receive antenatal care at a study clinic
- Unwillingness to stop iron folic acid supplementation to receive the study intervention
- Hemoglobin level below 70 g/L
- Pregnancy less than 6 weeks or 20 weeks or more gestation
- Non-viable or extrauterine pregnancy
- Any contraindications to study supplements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment until delivery (up to approximately 34 weeks gestation)
Participants take daily multiple micronutrient and calcium supplements, either concurrently or separately, from enrollment through the end of pregnancy. Monthly antenatal visits are conducted to collect information on supplement adherence, side effects, and anemia symptoms. Mid-pregnancy and late pregnancy visits include blood and health measurements.
Monthly antenatal visits and 2 additional visits at mid-pregnancy (20<24 weeks) and late pregnancy (30<34 weeks)
Duration - Within 72 hours after delivery
Within 72 hours after birth, participants' newborns have a heel prick blood sample collected to assess infant hemoglobin and iron status.
1 visit (in-person)
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
M
Monica Pasqualino, PhD
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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