[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632071":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":69,"collaborators":24,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":104,"whyStopped":24,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"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",[43,57],{"facility":44,"status":24,"city":45,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Hospital Sant Joan de Deu","Barcelona","08950","Spain","ES",{"type":50,"coordinates":51},"Point",[52,53],2.15899,41.38879,{"lat":53,"lon":52},[56],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},{"facility":58,"status":24,"city":45,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Hospital Sant Joan de Déu",{"type":50,"coordinates":60},[52,53],{"lat":53,"lon":52},[63,65],{"name":30,"role":34,"phone":47,"phoneExt":64,"email":36},"936009751",{"name":66,"role":34,"phone":47,"phoneExt":67,"email":68},"Carles Lerin","601106790","carleslerin@gmail.com",{"type":70,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100632071","phase-1-effects-of-5-methyltetrahydrofolic-acid-supplementation-on-maternal-health-and-one-carbon-metabolism-during-lactation-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":82,"type":83},36,"ESTIMATED","INTERVENTIONAL",[86,87],"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.",[90],"Breastfeeding",[92,93,94,95,96,97,98,99,100,101,102,103],"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":107,"type":108},"2026-04-02","ACTUAL",{"date":110,"type":83},"2026-04-15",{"date":112,"type":83},"2027-02-28",{"name":5,"class":6},2]