[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611487":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":58,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"National University Hospital, Singapore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention (myo-inositol and folic acid supplement)","EXPERIMENTAL","Participants in the intervention arm will receive a total of 4 g\u002Fday of myo-inositol and 300 mcg\u002Fday of folic acid, divided into two daily doses.",[13],"Dietary Supplement: Myo-inositol and folic acid supplement",{"label":15,"type":16,"description":17,"interventionNames":18},"Control (folic acid supplement)","ACTIVE_COMPARATOR","Participants in the control arm will receive a total of 300 mcg\u002Fday of folic acid, divided into two daily doses.",[19],"Dietary Supplement: Folic acid supplement",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Myo-inositol and folic acid supplement","Participants will take 4 capsules in the morning and 4 capsules in the evening, each capsule containing 500 mg of myo-inositol and 37.5 mcg of folic acid. Capsules are to be swallowed whole with a drink, starting from 12-16 weeks' gestation and continued until delivery.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Folic acid supplement","Participants will take 4 capsules in the morning and 4 capsules in the evening, each capsule containing 37.5 mcg of folic acid. Capsules are to be swallowed whole with a drink, starting from 12-16 weeks' gestation and continued until delivery.",[15],[32],{"name":33,"affiliation":34,"role":35},"Shiao-Yng Chan, MBBChir (UK), FRCOG (UK), PhD","National University of Singapore, National University Hospital Singapore, Institute for Human Development and Potential (A*STAR)","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Gladys Woon, Bsc","CONTACT","+65 6516 4134","gladys_woon@nuhs.edu.sg",[43],{"facility":44,"status":45,"city":46,"state":46,"zip":47,"country":46,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"National University Hospital","RECRUITING","Singapore","119228","SG",{"type":50,"coordinates":51},"Point",[52,53],103.85007,1.28967,{"lat":53,"lon":52},[56,57],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[61],{"name":62,"class":6},"National University of Singapore","100611487","antenatal-myo-inositol-supplementation-in-pre-existing-diabetes-100611487",false,"NCT07241221","Antenatal Myo-inositol Supplementation in Pre-existing Diabetes","Antenatal Myo-inositol Supplementation in Pre-existing Diabetes to Promote Normal Neonatal Outcomes","AMulet","Inclusion Criteria\n\n* Pregnant women aged 21 years to 45 years old at the time of recruitment\n* Ongoing, viable, singleton intrauterine pregnancy\n* Between 12+0 days-16+6 days weeks' gestation at recruitment\n* T2DM diagnosed by a documented 75g Oral Glucose Tolerance Test (OGTT) showing a fasting glucose of \\>7 mmol\u002FL or 2h glucose \\>11.1 mmol\u002FL, or an HbA1C \\>6.5%, either prior to pregnancy or during the first 16 weeks of the index pregnancy\n* Intend to receive antenatal care and give birth at NUH\n* Willing to provide written, informed consent\n* Able to swallow capsules and comply with trial procedures\n\nExclusion Criteria\n\n* Known or suspected fetal aneuploidy or genetic\u002Fstructural anomaly\n* Severe allergy to food items requiring carriage of an Epipen at all times","FEMALE","21 Years","45 Years",{"count":75,"type":76},182,"ESTIMATED","INTERVENTIONAL",[79],"NA","This feasibility pilot study aims to gather data that can guide the design of a larger, more comprehensive trial to establish the effects of myo-inositol supplementation on supporting healthy outcomes in pregnancies complicated by Type 2 Diabetes Mellitus (T2DM). It seeks to assess myo-inositol's potential to support fetal and neonatal health, and optimise maternity outcomes as a complementary approach and adjuvant to existing diabetes mellitus therapies, as well as investigate the underlying biological mechanisms.",[82],"Perinatal and Neonatal Outcomes in Pregnancies With Type 2 Diabetes Mellitus (T2DM)",[84,85,86,87,88,89,90,91,92,93,94,95],"Diabetes","Pregnancy","Myo-inositol","Folic acid","Dietary Supplement","Birthweight","Prematurity","Neonatal Intensive Care Unit Admission","Stillbirth","Neonatal Death","Neonatal Complications","Maternity Complications","2025-12-02",{"date":98,"type":99},"2025-12-09","ACTUAL",{"date":101,"type":76},"2025-12",{"date":103,"type":76},"2029-08-31",{"name":5,"class":6},1]