Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status
NCT Number: NCT06568315
Acronym: CaMMS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Anemia, Iron Deficiency
Interventions: DIETARY_SUPPLEMENT: Concurrent multiple micronutrient and calcium supplementation|DIETARY_SUPPLEMENT: Separate multiple micronutrient and calcium supplementation
Sponsor: Johns Hopkins Bloomberg School of Public Health
Collaborators: Institut Africain de Santé Publique (African Institute of Public Health)|Aga Khan University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 3200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2025-03
Completion Date: 2026-08
Locations: Institut Africain de Santé Publique (African Institute of Public Health), Ouagadougou, Burkina Faso|Aga Khan University, Karachi, Pakistan

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.

Primary Outcome Measures: Hemoglobin concentration of pregnant women, Hemoglobin measured by hematology analyzer, 30<34 weeks of gestation
Secondary Outcome Measures: Ferritin concentration, Ferritin (μg/L), 30<34 weeks of gestation|Soluble transferrin receptor (sTfR) concentration, sTfR (mg/L), 30<34 weeks of gestation|Hepcidin concentration, Hepcidin (ng/mL), 30<34 weeks of gestation|Erythropoietin (EPO) concentration, EPO (mIU/mL), 30<34 weeks of gestation|sTfR-Ferritin index, sTfR:log10(ferritin), 30<34 weeks of gestation|Hepcidin-EPO ratio, Hepcidin:EPO, 30<34 weeks of gestation|Red blood cell (RBC) count, RBC count, 30<34 weeks of gestation|Mean corpuscular volume (MCV), MCV (fL), 30<34 weeks of gestation|Mean corpuscular hemoglobin (MCH), MCH (pg), 30<34 weeks of gestation|Mean corpuscular hemoglobin concentration (MCHC), MCHC (g/dL), 30<34 weeks of gestation|Hemoglobin concentration of infants, Hemoglobin (g/L) measured by HemoCue, within 72 hours of birth|Ferritin concentration of infants, Ferritin (μg/L), within 72 hours of birth
Other Outcome Measures: Proportion of women with anemia, Hemoglobin \< 110 g/L, 30<34 weeks of gestation|Proportion of women with severe anemia (intervention safety), Hemoglobin \< 70 g/L, 20<24 weeks or 30<34 weeks of gestation|Proportion of women with iron deficiency, Ferritin \<15 μg/L (adjusted for inflammation), 30<34 weeks of gestation|Proportion of women with iron-deficient erythropoiesis, Elevated sTfR concentration, 30<34 weeks of gestation|Proportion of women with iron deficiency anemia, Concurrent anemia and iron deficiency, 30<34 weeks of gestation|Birth weight, Infant's birth weight (g), within 72 hours of birth|Proportion of infants born low birth weight, Infant weight \<2500 g, within 72 hours of birth|Gestational age, Gestational age at birth (weeks), within 72 hours of birth|Proportion of infants both preterm, Gestational age \<37 weeks, within 72 hours of birth|Weight-for-gestational age Z-score, Calculated using INTERGROWTH-21st standard, within 72 hours of birth|Proportion of infants born small for gestational age, \<10th percentile of weight-for-gestational age using INTERGROWTH-21st standard, within 72 hours of birth|Proportion of pregnancies ending in miscarriage, Fetal loss \<20 gestational weeks, <20 weeks of gestation|Proportion of pregnancies ending in stillbirth, Fetal loss ≥20 gestational weeks, ≥20 weeks of gestation