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Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status

RecruitingPhase 3Ages 15 Years - anyFemaleJohns Hopkins Bloomberg School of Public Health
NCT06568315 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Resea

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📋 Eligibility rules (as published)
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
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What it tests

  • Concurrent multiple micronutrient and calcium supplementation
  • Separate multiple micronutrient and calcium supplementation
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Where

2 sites
Institut Africain de Santé Publique (African Institute of Public Health)
Ouagadougou, Burkina Faso
Aga Khan University
Karachi, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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