protocolSection identificationModule nctId: NCT06319079, orgStudyIdInfo id: UCTH 2024, briefTitle: Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri, class: OTHER, descriptionModule briefSummary: 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 ) has been designed and developed as part of a key strategy to incorporate in 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 lactating women on the composition of human milk and the nutritional status of iron and DHA in infant red blood cells in a vulnerable population through a randomized, triple-blind, controlled clinical trial.Specific objectives To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc and Calcium in human milk before and after dietary supplementation with SMM.To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron before and after dietary supplementation with SMM.To analyze the relationship between micronutrients measured in maternal blood and human milk after dietary supplementation with SMM.To compare the concentrations of micronutrients measured in blood and human milk in women who received SMM and those who received commercial milk (CM) at the end of supplementation.To compare the iron nutritional status and DHA content in red blood cells of infants of mothers who consumed SMM or LC.To evaluate the relationship between the concentration of micronutrients in human milk and infant growth during the first six months of life., conditionsModule conditions: Lactating Mothers, conditions: Infants, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: The powder milk containers (both SMM and commercial milk) will be packaged by Addvance SA (in the Province of Santa Fe), each of the products will have a label that differentiates them but only the company Addvance SA will know that information. In this project, neither the participating mothers, researchers, and technical staff assigned to the project nor the professional who performs the data analysis knows what product each participant will receive., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Fortified powder milk, interventions name: Powder milk, outcomesModule primaryOutcomes measure: breast milk DHA concentration, primaryOutcomes measure: breast milk Vitamin A concentration, primaryOutcomes measure: breast milk Vitamin E concentration, primaryOutcomes measure: breast milk Vitamin D concentration, primaryOutcomes measure: breast milk Zinc concentration, primaryOutcomes measure: breast milk Calcium concentration, primaryOutcomes measure: breast milk Iron concentration, primaryOutcomes measure: breast milk Iodine concentration, secondaryOutcomes measure: mother red blood cell DHA concentration, secondaryOutcomes measure: mother Vit A concentration, secondaryOutcomes measure: mother Vit E concentration, secondaryOutcomes measure: mother Vit D concentration, secondaryOutcomes measure: mother Zinc concentration, secondaryOutcomes measure: mother hemoglobin concentration, secondaryOutcomes measure: mother serum ferritin concentration, secondaryOutcomes measure: child hemoglobin concentration, secondaryOutcomes measure: child serum ferritin concentration, secondaryOutcomes measure: child red blood cell DHA concentration, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False