[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559759":3},{"organization":4,"outcomesModule":7,"designInfo":93,"detailedDescription":104,"studyPopulation":96,"armGroups":105,"interventions":118,"overallOfficials":128,"centralContacts":133,"locations":142,"responsibleParty":183,"collaborators":185,"id":193,"slug":194,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":201,"sex":202,"minAge":203,"maxAge":96,"enrollmentInfo":204,"targetDuration":96,"studyType":207,"phases":208,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":145,"whyStopped":96,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},{"fullName":5,"class":6},"Johns Hopkins Bloomberg School of Public Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"Hemoglobin concentration of pregnant women","Hemoglobin measured by hematology analyzer","30\u003C34 weeks of gestation",[14,17,20,23,26,29,32,35,38,41,44,48],{"measure":15,"description":16,"timeFrame":12},"Ferritin concentration","Ferritin (μg\u002FL)",{"measure":18,"description":19,"timeFrame":12},"Soluble transferrin receptor (sTfR) concentration","sTfR (mg\u002FL)",{"measure":21,"description":22,"timeFrame":12},"Hepcidin concentration","Hepcidin (ng\u002FmL)",{"measure":24,"description":25,"timeFrame":12},"Erythropoietin (EPO) concentration","EPO (mIU\u002FmL)",{"measure":27,"description":28,"timeFrame":12},"sTfR-Ferritin index","sTfR:log10(ferritin)",{"measure":30,"description":31,"timeFrame":12},"Hepcidin-EPO ratio","Hepcidin:EPO",{"measure":33,"description":34,"timeFrame":12},"Red blood cell (RBC) count","RBC count",{"measure":36,"description":37,"timeFrame":12},"Mean corpuscular volume (MCV)","MCV (fL)",{"measure":39,"description":40,"timeFrame":12},"Mean corpuscular hemoglobin (MCH)","MCH (pg)",{"measure":42,"description":43,"timeFrame":12},"Mean corpuscular hemoglobin concentration (MCHC)","MCHC (g\u002FdL)",{"measure":45,"description":46,"timeFrame":47},"Hemoglobin concentration of infants","Hemoglobin (g\u002FL) measured by HemoCue","within 72 hours of birth",{"measure":49,"description":16,"timeFrame":47},"Ferritin concentration of infants",[51,54,58,61,64,67,70,73,76,79,82,85,89],{"measure":52,"description":53,"timeFrame":12},"Proportion of women with anemia","Hemoglobin \\\u003C 110 g\u002FL",{"measure":55,"description":56,"timeFrame":57},"Proportion of women with severe anemia (intervention safety)","Hemoglobin \\\u003C 70 g\u002FL","20\u003C24 weeks or 30\u003C34 weeks of gestation",{"measure":59,"description":60,"timeFrame":12},"Proportion of women with iron deficiency","Ferritin \\\u003C15 μg\u002FL (adjusted for inflammation)",{"measure":62,"description":63,"timeFrame":12},"Proportion of women with iron-deficient erythropoiesis","Elevated sTfR concentration",{"measure":65,"description":66,"timeFrame":12},"Proportion of women with iron deficiency anemia","Concurrent anemia and iron deficiency",{"measure":68,"description":69,"timeFrame":47},"Birth weight","Infant's birth weight (g)",{"measure":71,"description":72,"timeFrame":47},"Proportion of infants born low birth weight","Infant weight \\\u003C2500 g",{"measure":74,"description":75,"timeFrame":47},"Gestational age","Gestational age at birth (weeks)",{"measure":77,"description":78,"timeFrame":47},"Proportion of infants both preterm","Gestational age \\\u003C37 weeks",{"measure":80,"description":81,"timeFrame":47},"Weight-for-gestational age Z-score","Calculated using INTERGROWTH-21st standard",{"measure":83,"description":84,"timeFrame":47},"Proportion of infants born small for gestational age","\\\u003C10th percentile of weight-for-gestational age using INTERGROWTH-21st standard",{"measure":86,"description":87,"timeFrame":88},"Proportion of pregnancies ending in miscarriage","Fetal loss \\\u003C20 gestational weeks","\u003C20 weeks of gestation",{"measure":90,"description":91,"timeFrame":92},"Proportion of pregnancies ending in stillbirth","Fetal loss ≥20 gestational weeks","≥20 weeks of gestation",{"allocation":94,"interventionModel":95,"interventionModelDescription":96,"primaryPurpose":97,"observationalModel":96,"timePerspective":96,"maskingInfo":98},"RANDOMIZED","PARALLEL",null,"PREVENTION",{"masking":99,"maskingDescription":100,"whoMasked":101},"DOUBLE","Counseling messages and supplement packaging do not enable masking of participants or study staff with direct participant contact. Laboratory staff measuring the trial's outcomes and investigators will be masked.",[102,103],"INVESTIGATOR","OUTCOMES_ASSESSOR","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 the increased demands of the developing fetus. Studies show that antenatal micronutrient supplementation can have important benefits for maternal and infant health. While WHO currently recommends daily iron and folic acid supplementation, many countries are transitioning to multiple micronutrient supplementation (MMS) based on evidence of its further benefit in reducing risk of low birth weight, small-for-gestational age births, stillbirths, and preterm delivery. WHO also recommends calcium supplementation for women in settings where calcium intake is low to reduce high blood pressure and prevent preeclampsia and preterm birth.\n\nWomen are instructed to take calcium supplements separately from iron-containing supplements to avoid any negative impact of calcium on iron absorption. However, evidence that calcium limits iron absorption is largely from studies of single test meals. Research on the longer-term implications of consuming the two nutrients together for iron status and hemoglobin is limited, particularly in pregnancy. This is an important research question as limiting the number of times per day that a woman needs to take supplements is likely to improve adherence to the regimen. There is also interest in designing a new MMS formulation that includes calcium such that women could take a single tablet daily.\n\nThis individually randomized controlled non-inferiority trial will enroll 1,600 women in both Burkina Faso and Pakistan (3,200 in total) to assess the impact of co-administering calcium (500 mg elemental calcium as calcium carbonate) and multiple micronutrient supplements (including 30 mg elemental iron), compared with the currently recommended practice of taking the supplements at two separate times of the day, on hematological and iron status of pregnant women and the women's infants. The sample size is based on a non-inferiority margin of -3.0 g\u002FL, 90% power, a one-sided α=0.025, a standard deviation of 17 g\u002FL for the primary hemoglobin outcome, and 15% loss to follow-up.\n\nPotentially eligible women will be identified through antenatal care visits in Burkina Faso and household visits in Pakistan. For those who consent to screening, research staff will measure hemoglobin and conduct a fetal ultrasound exam. Inclusion and exclusion criteria are provided below. Research staff will obtain written documentation of informed consent.\n\nAt enrollment, women will be randomized, and research staff will collect socio-demographic data, take anthropometric and blood pressure measurements, and collect a venous blood sample. Women will receive counseling based on the randomly assigned intervention and be given a supply of study supplements. Research staff will see women monthly at antenatal visits to collect information on adherence by recall and pill count, side effects, signs\u002Fsymptoms of anemia, and information on any iron treatment that women may have received between visits. Iron treatment prescribed by providers outside of the trial will also be abstracted from medical records. At the mid-pregnancy (20\\\u003C24 weeks) and late pregnancy (30\\\u003C34 weeks) visits, research staff will take hemoglobin (HemoCue), anthropometric and blood pressure measurements and collect venous blood samples. Women with severe anemia (\\\u003C70 g\u002FL) will be referred for treatment. Within 72 hours of birth, research staff will collect a heel prick blood sample from infants. Blood samples will be processed at antenatal clinics and transferred to central laboratories for measurement of hematological parameters, iron status, and inflammation.",[106,112],{"label":107,"type":108,"description":109,"interventionNames":110},"Concurrent MMS \u002F Calcium","EXPERIMENTAL","Daily multiple micronutrient supplement (providing 30 mg iron) taken concurrently with daily calcium supplement (500 mg)",[111],"Dietary Supplement: Concurrent multiple micronutrient and calcium supplementation",{"label":113,"type":114,"description":115,"interventionNames":116},"Separate MMS \u002F Calcium","ACTIVE_COMPARATOR","Daily multiple micronutrient supplement (providing 30 mg iron) taken separately from daily calcium supplement (500 mg)",[117],"Dietary Supplement: Separate multiple micronutrient and calcium supplementation",[119,124],{"type":120,"name":121,"description":122,"armGroupLabels":123,"otherNames":96},"DIETARY_SUPPLEMENT","Concurrent multiple micronutrient and calcium supplementation","Participants counseled to take United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) multiple micronutrient supplement providing 30 mg elemental iron and calcium supplement providing 500 mg elemental calcium as 1250 mg calcium carbonate together every morning from enrollment through the end of pregnancy",[107],{"type":120,"name":125,"description":126,"armGroupLabels":127,"otherNames":96},"Separate multiple micronutrient and calcium supplementation","Participants counseled to take United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) multiple micronutrient supplement (MMS) providing 30 mg elemental iron every morning and calcium supplement providing 500 mg elemental calcium as 1250 mg calcium carbonate every evening from enrollment through the end of pregnancy",[113],[129],{"name":130,"affiliation":131,"role":132},"Amanda Palmer, PhD","Johns Hopkins University","PRINCIPAL_INVESTIGATOR",[134,139],{"name":135,"role":136,"phone":137,"phoneExt":96,"email":138},"Amanda C Palmer, PhD","CONTACT","1 (410) 955-2061","acpalmer@jhu.edu",{"name":140,"role":136,"phone":96,"phoneExt":96,"email":141},"Monica Pasqualino, PhD","mpasqua2@jhmi.edu",[143,165],{"facility":144,"status":145,"city":146,"state":96,"zip":96,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":154,"contacts":155},"Institut Africain de Santé Publique (African Institute of Public Health)","RECRUITING","Ouagadougou","Burkina Faso","BF",{"type":150,"coordinates":151},"Point",[152,153],-1.53388,12.36566,{"lat":153,"lon":152},[156,160,162],{"name":157,"role":136,"phone":158,"phoneExt":96,"email":159},"Seni Baguiya, PhD","70 26 14 62","senikouanda@gmail.com",{"name":161,"role":132,"phone":96,"phoneExt":96,"email":96},"Seni Kouanda, PhD",{"name":163,"role":164,"phone":96,"phoneExt":96,"email":96},"Adama Baguiya, MD","SUB_INVESTIGATOR",{"facility":166,"status":145,"city":167,"state":96,"zip":96,"country":168,"countryCode":169,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Aga Khan University","Karachi","Pakistan","PK",{"type":150,"coordinates":171},[172,173],67.0104,24.8608,{"lat":173,"lon":172},[176,180,182],{"name":177,"role":136,"phone":178,"phoneExt":96,"email":179},"Saleem Jessani, MBBS","021-34864885","saleem.jessani@aku.edu",{"name":181,"role":132,"phone":96,"phoneExt":96,"email":96},"Sarah Saleem, MBBS",{"name":177,"role":164,"phone":96,"phoneExt":96,"email":96},{"type":184,"investigatorFullName":96,"investigatorTitle":96,"investigatorAffiliation":96,"oldNameTitle":96,"oldOrganization":96},"SPONSOR",[186,188,189,191],{"name":144,"class":187},"UNKNOWN",{"name":166,"class":6},{"name":190,"class":6},"Bill and Melinda Gates Foundation",{"name":192,"class":6},"Children's Investment Fund Foundation","100559759","co-administration-of-calcium-and-multiple-micronutrient-supplements-for-maternal-and-newborn-hemoglobin-and-iron-status-100559759",false,"NCT06568315","Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status","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","CaMMS","Inclusion Criteria:\n\n* Burkina Faso: married or unmarried pregnant women aged ≥15 years\n* Pakistan: married pregnant women ≥18 years\n* Willing to receive all antenatal care at a study clinic\n* Willing to stop iron folic acid supplementation to receive the study intervention\n* Hb ≥70 g\u002FL\n* 6\\\u003C20 weeks of gestation based on fetal ultrasound\n\nExclusion Criteria:\n\n* Burkina Faso: \\\u003C15 years or unmarried pregnant women \\\u003C18 years without consent from parent \u002F guardian\n* Pakistan: pregnant women \\\u003C18 years.\n* Unwilling to receive antenatal care at a study clinic\n* Unwilling to stop iron folic acid supplementation to receive the study intervention\n* Hemoglobin \\\u003C 70 g\u002FL\n* \\\u003C6 weeks of gestation or ≥20 weeks of gestation\n* Non-viable or extrauterine pregnancy\n* Any contraindications to study supplements",true,"FEMALE","15 Years",{"count":205,"type":206},3200,"ESTIMATED","INTERVENTIONAL",[209],"PHASE3","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.",[212],"Anemia, Iron Deficiency",[214,215,216,217,218],"calcium","iron","supplementation","anemia","pregnancy","2026-08-06",{"date":221,"type":222},"2026-08-10","ACTUAL",{"date":224,"type":222},"2025-08-25",{"date":226,"type":206},"2027-04",{"name":5,"class":6},2]