[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632071":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":68,"collaborators":24,"id":70,"slug":24,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":24,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":102,"whyStopped":24,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Fundació Sant Joan de Déu","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"5-MTHF Supplementation","EXPERIMENTAL","Dietary Supplement (5-MTHF)",[13],"Dietary Supplement: 5-MTHF Supplementation",{"label":15,"type":16,"description":15,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT","Oral supplementation with 5-MTHF (800 µg) administered daily for 6 weeks during lactation.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Matching placebo administered daily for 6 weeks during lactation.",[15],[29],{"name":30,"affiliation":5,"role":31},"Carles Lerin, PhD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","(+34) 93 600 97 51","carles.lerin@sjd.es",{"name":38,"role":34,"phone":39,"phoneExt":40,"email":41},"Marta Ramon Krauel, MD PhD","(+34) 93 280 40 00","Ext. 71263","marta.ramon@sjd.es",[43,56],{"facility":44,"status":24,"city":45,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hospital Sant Joan de Deu","Barcelona","08950","Spain",{"type":49,"coordinates":50},"Point",[51,52],2.15899,41.38879,{"lat":52,"lon":51},[55],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},{"facility":57,"status":24,"city":45,"state":45,"zip":46,"country":47,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"Hospital Sant Joan de Déu",{"type":49,"coordinates":59},[51,52],{"lat":52,"lon":51},[62,64],{"name":30,"role":34,"phone":47,"phoneExt":63,"email":36},"936009751",{"name":65,"role":34,"phone":47,"phoneExt":66,"email":67},"Carles Lerin","601106790","carleslerin@gmail.com",{"type":69,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100632071",false,"NCT07508917","Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation","OCMS","Inclusion Criteria:\n\n* Maternal age between 18 and 42 years\n* Gestational age at birth ≥ 37 weeks.\n* Exclusive breastfeeding at enrollment.\n* Infant age 0-1 months\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Presence of disease or malformations in the infant.\n* Weight-Standard Deviation Score \\\u003C -1 at enrollment.\n* Use of folate-containing multivitamin supplements during breastfeeding","FEMALE","18 Years","42 Years",{"count":80,"type":81},36,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","This double-blind, randomized, placebo-controlled parallel trial evaluates the effects of maternal 5-methyltetrahydrofolate (5-MTHF) supplementation during breastfeeding. Thirty-six lactating mother-infant dyads will be randomized (1:1) to receive 5-MTHF or placebo for 6 weeks, stratified by infant sex and mode of delivery. Tolerability and adverse events will be monitored.\n\nPre- and post-intervention assessments include breast milk one-carbon metabolites and oligosaccharides; maternal plasma one-carbon metabolites and metabolic health markers. Maternal mental health will be evaluated using the SCL-90-R questionnaire. A follow-up visit at 4 months will reassess infant anthropometry and microbiome outcomes.",[88],"Breastfeeding",[90,91,92,93,94,95,96,97,98,99,100,101],"5-Methyltetrahydrofolate (5-MTHF)","One-carbon metabolism","Human milk oligosaccharides","Breast milk composition","Betaine","Early-life nutrition","Maternal supplementation","Maternal mental health","5-MTHF","Gut Microbiome","Metabolomics","Infant Microbiota","NOT_YET_RECRUITING","2026-03-27",{"date":105,"type":106},"2026-04-02","ACTUAL",{"date":108,"type":81},"2026-04-15",{"date":110,"type":81},"2027-02-28",{"name":5,"class":6},2]