[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621335":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":27,"locations":24,"responsibleParty":33,"collaborators":35,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":24,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":61,"whyStopped":24,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":24},{"fullName":5,"class":6},"Obstetrics & Gynecology Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Melatonin","EXPERIMENTAL","1. Melatonin tablets will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal.\n2. Participants will take 5 mg melatonin every night during the first week of intervention after randomization, followed by 10 mg melatonin every night from the second week until delivery.",[13],"Drug: Melatonin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","1. Identical placebo tablets in terms of packaging, appearance, smell and taste will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal.\n2. Participants will take identical placebo tablets after randomization until delivery.",[19],"Other: Placebo",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":6,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":24,"email":32},"Yanting Wu, PhD","CONTACT","8621-17321218018","yanting_wu@163.com",{"type":34,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[36],{"name":37,"class":6},"West China Second University Hospital","100621335","phase-2-melatonin-for-glycemic-control-in-gestational-diabetes-mellitus-100621335",false,"NCT07369284","Melatonin for Glycemic Control in Gestational Diabetes Mellitus","Efficacy of Melatonin in Addition to Standard Care in Glycemic Control of Patients With Gestational Diabetes Mellitus: a Randomized, Double-blind, Placebo-controlled Trial","MELODY","Inclusion Criteria:\n\n* Women aged 18 to 45 years\n* Singleton pregnancy\n* A diagnosis of GDM from a 75-g OGTT during 24 to 28 gestational weeks, according to the IADPSG criteria, with at least fasting plasma glucose (FPG) ≥ 5.1 mmol\u002FL\n* Intending to receive obstetric care and deliver in the study center\n* Willing and able to provide written informed consent and follow the study procedure\n\nExclusion Criteria:\n\n* Use of melatonin 1 month before pregnancy or\u002Fand during pregnancy\n* Night shift work or exposed to jetlag on a regular basis during pregnancy\n* Contraindications to melatonin use, including hypersensitive or allergic to melatonin\n* Use of antidepressive or antipsychotic medications which can interfere with melatonin metabolism and\u002For elimination, such as fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, quinolones, and other CYP1A2 inhibitors; carbamazepine, rifampicin, and other CYP1A2 inducers; and zaleplon, zolpidem, zopiclone, and other non-benzodiazepine hypnotics\n* Pre-pregnancy diabetes, including patients diagnosed with diabetes before conception, fasting plasma glucose ≥ 7.0 mmol\u002FL or HbA1c ≥ 6.5% in the first trimester, typical hyperglycemic symptoms or hyperglycemic crisis with random blood glucose ≥ 11.1 mmol\u002FL\n* Other major diseases before gestation, e.g. hypertensive disorders, rheumatology or malignant diseases, infected with hepatitis B or hepatitis C, chronic diseases leading to impaired heart, liver, or renal function\n* Major fetal anomalies","FEMALE","18 Years","45 Years",{"count":50,"type":51},150,"ESTIMATED","INTERVENTIONAL",[54],"PHASE2","The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether melatonin supplementation improves glycemic control in pregnant women diagnosed with gestational diabetes mellitus (GDM).\n\nThe main question it aims to answer is:\n\nDoes melatonin supplementation help with glycemic control, especially in lowering fasting plasma glucose level?\n\nResearchers will compare melatonin to a placebo (a look-alike substance that contains no melatonin) to see if melatonin works to improve glycemic control.\n\nParticipants will:\n\n1. Take melatonin or a placebo every day after randomization until delivery\n2. Visit the antenatal clinic once every 1 to 2 weeks for follow-ups",[57],"Gestational Diabetes",[59,9,60],"Gestational diabetes","Fasting plasma glucose","NOT_YET_RECRUITING","2026-01-17",{"date":64,"type":65},"2026-01-27","ACTUAL",{"date":67,"type":51},"2026-02",{"date":69,"type":51},"2027-08",{"name":5,"class":6}]