NCT06568315 Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status
| NCT ID | NCT06568315 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Johns Hopkins Bloomberg School of Public Health |
| Condition | Anemia, Iron Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,200 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 3,200 participants in total. It began in 2025-08-25 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Amanda Palmer, PhD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06568315 clinical trial?
This trial is open to female participants only, aged 15 Years or older, studying Anemia, Iron Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06568315 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 3,200 participants.
Is NCT06568315 currently recruiting?
Yes, NCT06568315 is actively recruiting participants. Contact the research team at acpalmer@jhu.edu for enrollment information.
Where is the NCT06568315 trial being conducted?
This trial is being conducted at Ouagadougou, Burkina Faso, Karachi, Pakistan.
Who is sponsoring the NCT06568315 clinical trial?
NCT06568315 is sponsored by Johns Hopkins Bloomberg School of Public Health. The principal investigator is Amanda Palmer, PhD at Johns Hopkins University. The trial plans to enroll 3,200 participants.