Taking calcium and iron-containing multivitamin supplements together during pregnancy
Official title: 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
Run by Johns Hopkins Bloomberg School of Public Health · NCT06568315 · Data updated 2026-11-12
This trial will test whether pregnant women can take daily calcium at the same time as iron-containing multiple micronutrients without harming their or their newborns' hemoglobin and iron levels.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 15 Years and up |
| Sex | Women only |
| Enrollment | 3200 (estimated) |
| Sponsor | Johns Hopkins Bloomberg School of Public Health Academic / other |
| Locations | 2 sites (Ouagadougou and 1 other locations) |
| Status | Recruiting |
| Started | August 25, 2025 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT06568315 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women in the study sites (Burkina Faso or Pakistan) between 6 and <20 weeks gestation with hemoglobin ≥70 g/L who are willing to receive all antenatal care at a study clinic and replace routine iron-folic acid with the study supplements.
✕Probably not a fit
Women with severe anemia (hemoglobin <70 g/L), those outside the 6–<20 week gestation window, or those unwilling to attend the study clinic or stop routine iron-folic acid may not benefit from or be eligible for this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Pregnant women 6 to <20 weeks gestation are randomly assigned to take a multiple micronutrient supplement and calcium either together each morning or separated (micronutrient in the morning and calcium in the evening). Participants attend monthly antenatal visits with blood samples collected in early, mid, and late pregnancy and cord or infant blood sampled at birth to measure hemoglobin and iron status. The trial is conducted at study clinics in Burkina Faso and Pakistan and requires participants to receive antenatal care at the study site and stop routine iron-folic acid supplements while enrolled. The aim is to determine whether co-administration affects iron status and whether a simpler dosing schedule could improve adherence and inform future supplement formulations.
Why it matters
Potential benefit: If successful, the findings could allow pregnant women to take fewer separate pills each day, improving adherence while maintaining healthy hemoglobin and iron levels for mothers and babies.
How similar studies have gone: Multiple micronutrient supplementation has shown benefits for birth outcomes, but studies examining long-term effects of taking calcium and iron together in pregnancy are limited and mostly based on short-term meal studies rather than randomized antenatal trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Institut Africain de Santé Publique (African Institute of Public Health)
Ouagadougou, Burkina Faso Recruiting -
Aga Khan University
Karachi, Pakistan Recruiting
Study contacts
- Principal investigator: Amanda Palmer, PhD — Johns Hopkins University
- Study coordinator: Amanda C Palmer, PhD
- Email: acpalmer@jhu.edu
- Phone: 1 (410) 955-2061
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.