[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606309":3},{"organization":4,"outcomesModule":7,"designInfo":70,"detailedDescription":69,"studyPopulation":69,"armGroups":81,"interventions":92,"overallOfficials":69,"centralContacts":98,"locations":104,"responsibleParty":134,"collaborators":136,"id":139,"slug":69,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":69,"eligibilityCriteria":144,"healthyVolunteers":145,"sex":146,"minAge":147,"maxAge":69,"enrollmentInfo":148,"targetDuration":69,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":107,"whyStopped":69,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":69,"otherOutcomes":69},[9,13,17,21,25,29,33,37,41,45,49,53,57,61,65],{"measure":10,"description":11,"timeFrame":12},"Breast milk DHA concentration","Description: concentration of DHA in breast milk expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample","Time Frame: breast milk DHA concentration will be assessed at one month postpartum.",{"measure":14,"description":15,"timeFrame":16},"Mother Zinc concentration","Zinc concentration in mother serum expressed in mg\u002Fdl","Mother Zinc concentration will be assessed at one month postpartum",{"measure":18,"description":19,"timeFrame":20},"mother Vit E concentration","α-tocopherol concentration in mother serum expressed in μmol\u002FL","Mother's serum α-tocopherol concentration will be assessed at one month postpartum",{"measure":22,"description":23,"timeFrame":24},"Mother Vit A concentration","Retinol concentration in mother serum expressed in μmol\u002FL","Mother's Vit A concentration will be assessed at one month postpartum",{"measure":26,"description":27,"timeFrame":28},"Mother red blood cell DHA concentration","Concentration of DHA in mother's red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample","Mother's serum DHA concentration will be assessed at one month postpartum",{"measure":30,"description":31,"timeFrame":32},"Mother hemoglobin concentration","hemoglobin concentration in mother serum expressed in g\u002FdL","Mother's hemoglobin concentration will be assessed one month postpartum",{"measure":34,"description":35,"timeFrame":36},"Breast milk Vitamin A concentration","Retinol concentration in breast milk expressed in μmol\u002FL and μg\u002Fg fat contained in the analyzed sample","Breast milk Vitamin A concentration will be assessed at one month postpartum",{"measure":38,"description":39,"timeFrame":40},"Breast milk Vitamin E concentration","α-tocopherol concentration in breast milk expressed in μmol\u002FL and μg\u002Fg fat contained in the analyzed sample","Breast milk Vitamin E concentration will be assessed at one month postpartum",{"measure":42,"description":43,"timeFrame":44},"Breast milk Vitamin D concentration","25-hidroxi vitamin D concentration in breast milk expressed in ng\u002Fml","Breast milk Vitamin D concentration will be assessed at one month postpartum",{"measure":46,"description":47,"timeFrame":48},"Breast milk Zinc concentration","Zinc concentration in breast milk expressed in mg\u002Fdl","Breast milk Zinc concentration will be assessed at one month postpartum",{"measure":50,"description":51,"timeFrame":52},"Breast milk Calcium concentration","Calcium concentration in breast milk expressed in mg\u002Fdl","Breast milk Calcium concentration will be assessed at one month postpartum",{"measure":54,"description":55,"timeFrame":56},"Breast milk Iron concentration","Iron concentration in breast milk expressed in mg\u002Fdl","Breast milk Iron concentration will be assessed at one month postpartum",{"measure":58,"description":59,"timeFrame":60},"Breast milk Iodine concentration","Iodine concentration in breast milk expressed in mg\u002Fdl","Breast milk Iodine concentration will be assessed at one month postpartum",{"measure":62,"description":63,"timeFrame":64},"Mother serum ferritin concentration","ferritin concentration in mother serum expressed in ng\u002Fml","Mother's serum ferritin concentration will be assessed at one month postpartum",{"measure":66,"description":67,"timeFrame":68},"mother Vit D concentration","25-hidroxi vitamin D concentration in mother serum expressed in ng\u002Fml","mother Vit D concentration will be assessed at one month postpartum",null,{"allocation":71,"interventionModel":72,"interventionModelDescription":69,"primaryPurpose":73,"observationalModel":69,"timePerspective":69,"maskingInfo":74},"NON_RANDOMIZED","PARALLEL","PREVENTION",{"masking":75,"maskingDescription":69,"whoMasked":76},"QUADRUPLE",[77,78,79,80],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[82,88],{"label":83,"type":84,"description":85,"interventionNames":86},"Experimental: Super 1.000 Mamá","EXPERIMENTAL","Pregnant women who will consume a fortified powdered dairy product formulated and designed specifically for this population during pregnancy and the first month postpartum.",[87],"Dietary Supplement: Fortified powder milk",{"label":89,"type":90,"description":91,"interventionNames":69},"Sham Comparator: No milk consumption","NO_INTERVENTION","Breastfeeding women who have not consumed SMM until the first month postpartum",[93],{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":69},"DIETARY_SUPPLEMENT","Fortified powder milk","Super 1.000 Mamá It's made up of milk with added vegetable oils, fish oil, carbohydrates from corn, prebiotic fiber (inulin), vitamins, and minerals, with specifically defined proportions. It has medium energy content, is balanced in protein, fats, and carbohydrates, and provides a significant content of both polyunsaturated fatty acids, such as omega-6, and omega-3, and the added docosahexaenoic acid, as recommended by international organizations. The reconstituted 200 ml serving delivers between 20 and 40% of the Daily Reference Intake in critical nutrients for this particular group of people, which include minerals such as calcium, iron, zinc, iodine, and vitamins such as A, D, C, B12 and folic acid. The rest of the vitamins, and minerals are also at the same level, allowing those who consume it to incorporate a large amount of nutrients regularly. Addvance SA, an SME dairy company from the Province of Santa Fe, will carry out the production of this milk.",[83],[99],{"name":100,"role":101,"phone":102,"phoneExt":69,"email":103},"Maria F Andreoli, PhD","CONTACT","542214177324","mfandreoli@gmail.com",[105,124],{"facility":106,"status":107,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"Hospital Interzonal de Agudos General San Martín","RECRUITING","La Plata","Buenos Aires","1900","Argentina","AR",{"type":114,"coordinates":115},"Point",[116,117],-57.95442,-34.92126,{"lat":117,"lon":116},[120],{"name":121,"role":101,"phone":122,"phoneExt":69,"email":123},"Sofia A Rui, Bachelor degree nutrition","5492281566075","sofiaarui@hotmail.com",{"facility":125,"status":107,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":126,"geoPoint":128,"contacts":129},"Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica",{"type":114,"coordinates":127},[116,117],{"lat":117,"lon":116},[130],{"name":131,"role":101,"phone":132,"phoneExt":69,"email":133},"Ignacio A Mendez, MS Nutrition","01158671615","ignacioagustinmg@gmail.com",{"type":135,"investigatorFullName":69,"investigatorTitle":69,"investigatorAffiliation":69,"oldNameTitle":69,"oldOrganization":69},"SPONSOR",[137],{"name":106,"class":138},"UNKNOWN","100606309",false,"NCT07173881","Effect of a Dairy Product for Pregnant and Lactating Women on the Composition of Human Milk","Effect of Consumption of a Dairy Product Designed for Pregnant and Lactating Women on the Composition of Human Milk. A Quasi-experimental Study in a Vulnerable Population","Inclusion Criteria:\n\n* Intervention group: Pregnant women over 18 years of age who undergo prenatal care during gestational weeks (GW) 28 ± 1 at the Maternal Nutrition Clinic of the H.I.G.A. \"San Martín\" in La Plata, and who regularly consume milk, will be included.\n* Control group: Women over 18 years of age who attend their child's first checkup before the first month of life at the Maternal Clinic of the IDIP Health Observatory, and who exclusively breastfeed their children, will be included.\n\nExclusion Criteria:\n\n* Women who have had multiple pregnancies and\u002For women with malabsorption diseases.",true,"FEMALE","18 Years",{"count":149,"type":150},20,"ESTIMATED","INTERVENTIONAL",[153],"NA","Vulnerable populations, who have deficient diets, may produce human milk (HML) that is not adequate in all nutrients, and this will have consequences on the growth and development of the child. In 2021, at IDIP, a specific milk product for pregnant and lactating women, Super Mil Mamá ( SMM, whole milk powder fortified with multiple vitamins, minerals, and DHA ) was designed and developed as part of a key strategy to incorporate into public policies for the first 1000 days of life. However, the potential benefits of this product have not yet been evaluated at the population level. The main objective is to evaluate the effect of the consumption of a milk product (SMM) designed for pregnant women on maternal nutritional status and the composition of human milk at one month postpartum.\n\nSpecific objectives include:\n\nTo compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc, and Calcium in human milk at one month postpartum of mothers who consumed SSM or not.\n\nTo compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron between mothers who consumed SSM and those who did not.",[156],"Pregnancy",[158,159,160,161,162,163],"human milk","vulnerable population","pregnancy","nutritional supplements","esencial fatty acids","micronutrients","2025-09-12",{"date":166,"type":167},"2025-09-15","ACTUAL",{"date":169,"type":167},"2025-08-01",{"date":171,"type":150},"2026-01-30",{"name":5,"class":6},2]