[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448519":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin group","EXPERIMENTAL","The patients will be obtain Metformin starting from 50mg everyday to 1-2g per day for 6 months.",[13],"Drug: Metformin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","The patients will be obtain starch tablets starting from 50mg everyday to 1-2g per day for 6 months.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Metformin","The patients in this group will be obtain Metformin starting from 50mg everyday at night, and gradually increase to maximum tolerable dose of 1-2g per day according to weights of patients for 6 months.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","The patients in this group will be obtain starch tablets (which had same appearance and size comparing to Metformin) starting from 50mg everyday to 1-2g per day according to weights of patients for 6 months.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Qiong Xu, Phd MD","CONTACT","862164931275","stellaxuqiong@hotmail.com",{"name":38,"role":34,"phone":35,"phoneExt":26,"email":39},"Chunchun Hu, MD","14211240007@fudan.edu.com",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Shanghai","Shanghai Municipality","201102","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":26,"phoneExt":26,"email":36},"Qiong Xu, PhD",{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100448519","phase-4-metformin-in-children-with-fragile-x-syndrome-100448519",false,"NCT05120505","Metformin in Children With Fragile X Syndrome","Efficacy and Safety of Metformin in the Treatment of Fragile X Syndrome","Inclusion Criteria:\n\n* Genetic testing confirms the diagnosis of FXS\n* Participate in the study with the informed consent of the guardian\n* BMI\\>the 3rd percentile\n* Not taking more than 2 therapeutic drugs\n* Able to receive regular follow-up visits\n\nExclusion Criteria:\n\n* Malnutrition\n* Primary heart disease\n* Severe infection or acute clinical illness\n* Gastrointestinal, renal, or hepatic disease\n* Previous history of lactic acidosis\n* previous use of metformin intolerant\n* Use of angiotensin converting enzyme inhibitors, use of anticoagulants, vitamin B12 deficiency, alcohol consumption\n* Unstable systemic diseases other than FXS\n* Changes in clinical medication","ALL","2 Years","16 Years",{"count":70,"type":71},20,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","This study is a controlled trial of metformin in children with fragile X syndrome(FXS). The age of FXS children range from 2 to 16 years old. Participants will be randomized in a double-blind design to either drug or placebo for 6-month period. The primary objectives are to assess metformin in treatment of behavior problems, cognitive and language with fragile X syndrome.",[77,23],"Fragile X Syndrome","2025-02-16",{"date":80,"type":81},"2025-02-18","ACTUAL",{"date":83,"type":81},"2021-12-29",{"date":85,"type":71},"2025-12-30",{"name":5,"class":6},1]