Status:
RECRUITING
Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Institut Africain de Santé Publique (African Institute of Public Health)
Aga Khan University
Conditions:
Anemia, Iron Deficiency
Eligibility:
FEMALE
15+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Women of reproductive age in low-and-middle-income countries typically consume diets inadequate in many micronutrients. Resulting micronutrient deficiencies are further exacerbated during pregnancy by...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Burkina Faso: \<15 years or unmarried pregnant women \<18 years without consent from parent / guardian
- Pakistan: pregnant women \<18 years.
- Unwilling to receive antenatal care at a study clinic
- Unwilling to stop iron folic acid supplementation to receive the study intervention
- Hemoglobin \< 70 g/L
- \<6 weeks of gestation or ≥20 weeks of gestation
- Non-viable or extrauterine pregnancy
- Any contraindications to study supplements
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
3200 Patients enrolled
Trial Details
Trial ID
NCT06568315
Start Date
August 25 2025
End Date
August 1 2026
Last Update
September 17 2025
Active Locations (2)
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1
Institut Africain de Santé Publique (African Institute of Public Health)
Ouagadougou, Burkina Faso
2
Aga Khan University
Karachi, Pakistan