[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"human-milk\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:human-milk":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100649515","vitamin-a-supplementation-and-breast-milk-vitamin-a-levels-in-mothers-of-preterm-infants-100649515",false,"NCT07736768","Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants","The Impact of Maternal Daily Oral High-Dose Vitamin A Supplementation on Vitamin A Concentration in Breast Milk of Mothers of Preterm Infants","VITAL","Inclusion Criteria:\n\n* Mothers aged 18 to 45 years Delivered an infant born at less than 29 weeks' gestation Intending to provide breast milk for at least 4 months postpartum Willing and able to swallow oral tablets Willing to comply with study procedures, including blood draws and breast milk collection at scheduled time points Able to provide written informed consent\n\nExclusion Criteria:\n\n* Age less than 18 or greater than 45 years Contraindications to breastfeeding or inability to provide breast milk Known liver disease or conditions affecting vitamin A metabolism (e.g., chronic liver disease, known hypervitaminosis A) Baseline elevated vitamin A levels above the normal reference range Multiple gestation pregnancy (if you intend to exclude this-remove if not required) Known substance use disorder that may interfere with adherence or safety Infants with major congenital anomalies or known syndromic conditions Maternal refusal or inability to provide informed consent Planned discontinuation of breastfeeding within 4 months postpartum","ALL","18 Years","45 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"NA","Preterm infants are at increased risk of vitamin A deficiency because they are born with low vitamin A stores and depend largely on breast milk to meet their nutritional needs. This study will evaluate whether daily maternal vitamin A supplementation increases vitamin A concentrations in the breast milk of mothers who deliver infants before 29 weeks of gestation.\n\nParticipants will receive a commercially available oral multivitamin supplement containing 1,300 mcg retinol activity equivalents (RAE) of vitamin A daily for four months after delivery. Breast milk samples will be collected at 2 weeks, 2 months, and 4 months postpartum to measure vitamin A concentrations. The study will assess whether maternal supplementation is a feasible approach for increasing breast milk vitamin A concentrations in mothers of preterm infants.",[28,29,30,31,32],"Premature","Preterm Infant Health","Vitamin A Deficiency","Human Milk","Breastfeeding",[34,35,36,37,38,39,40],"vitamin a supplementation","human milk retinol","breast milk vitamin A","infant nutrition","milk micronutrients","lactation","feasibility study","NOT_YET_RECRUITING","2026-07-26",{"date":44,"type":45},"2026-07-30","ACTUAL",{"date":47,"type":22},"2026-08-01",{"date":49,"type":22},"2027-11-01",{"name":51,"class":52},"University of Mississippi Medical Center","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":53},"100519381","umbrellact-study-clinical-lactation-study-on-the-exposure-to-medicines-via-human-milk-100519381","NCT06042803","UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk","Clinical Lactation Study on the Exposure to Medicines Via Human Milk: an Umbrella Study Protocol","UmbrelLACT","Inclusion Criteria:\n\n* For breastfeeding women\n\n  * Maternal age: ≥ 18 year\n  * Currently exclusively or partially breastfeeding (\u002Fexpressing milk) at the time of milk sampling\n  * Using medicines for any indication, with at least 5 half-lives of the medicine taken\n  * Willing to express and collect human milk\n  * Signed informed consent to participate and for processing their personal data\n* For infants\n\n  * Gestational age at birth: ≥24 weeks\n  * Parental signed informed consent to participate and for processing their personal data\n\nExclusion Criteria:\n\n* Maternal age \\\u003C18 years\n* Mother of twins\n* Not meeting the inclusion criteria",true,"FEMALE",{"count":65,"type":22},30,"OBSERVATIONAL","The goal of this observational study is to determine the concentration of medicines in human milk during maternal medicine intake. The main questions it aims to answer are:\n\n* What is the concentration of maternal medicines in human milk?\n* What is the (estimated) intake and exposure in the breastfed infant?\n\nParticipants will be asked to\n\n* fill out a questionnaire regarding medical data of the mother and child\n* track medication intake for 3 days\n* collect milk samples during 24 hours\n* optionally, donate 2 blood samples of the mother and give consent to one blood sample of the child\n* fill out a questionnaire regarding the general health of the child.",[69,31],"Breast Feeding",[71,72,73,74,75,76,77,78],"Infant exposure","Physiologically-based pharmacokinetic models","Neonatology","breastfeeding","Pharmacology","Medicines","Drug transfer","Medication intake","RECRUITING","2025-02-24",{"date":82,"type":45},"2025-02-27",{"date":84,"type":45},"2023-02-01",{"date":86,"type":22},"2027-02",{"name":88,"class":52},"Universitaire Ziekenhuizen KU Leuven"]