[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558638":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":53,"centralContacts":60,"locations":69,"responsibleParty":105,"collaborators":49,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":49,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":49,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":72,"whyStopped":49,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Huazhong University of Science and Technology","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Vitamin D3 + Prebiotics","ACTIVE_COMPARATOR","Vitamin D3 (cholecalciferol), 1600 IU per day. Prebiotics (inulin), 10g per day.",[13,14],"Drug: Vitamin D3","Dietary Supplement: Prebiotics",{"label":16,"type":10,"description":17,"interventionNames":18},"Vitamin D3 + Prebiotics placebo","Vitamin D3 (cholecalciferol), 1600 IU per day. Prebiotics placebo.",[13,19],"Dietary Supplement: Prebiotics placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Prebiotics +Vitamin D3 placebo","Prebiotics (inulin), 10g per day. Vitamin D3 placebo.",[14,24],"Dietary Supplement: Vitamin D3 placebo",{"label":26,"type":27,"description":28,"interventionNames":29},"Vitamin D3 placebo + Prebiotics placebo","PLACEBO_COMPARATOR","Vitamin D3 placebo. Prebiotics placebo.",[19,24],[31,38,45,50],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Vitamin D3","Vitamin D3 (cholecalciferol), 1600 IU per day.",[9,16],[37],"Cholecalciferol",{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DIETARY_SUPPLEMENT","Prebiotics","Prebiotics (inulin), 10g per day.",[21,9],[44],"Inulin",{"type":39,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Prebiotics placebo","Prebiotics placebo.",[16,26],null,{"type":39,"name":51,"description":51,"armGroupLabels":52,"otherNames":49},"Vitamin D3 placebo",[21,26],[54,58],{"name":55,"affiliation":56,"role":57},"Gang Liu, PHD","School of Public Health, Tongji Medical College, Huazhong University of Science and Technology","PRINCIPAL_INVESTIGATOR",{"name":59,"affiliation":56,"role":57},"An Pan, PHD",[61,65],{"name":55,"role":62,"phone":63,"phoneExt":49,"email":64},"CONTACT","86-15926238366","liugang026@hust.edu.cn",{"name":66,"role":62,"phone":67,"phoneExt":49,"email":68},"Yuwei Lai, BM","86-13247125977","laiyuwei918@163.com",[70,87],{"facility":71,"status":72,"city":73,"state":74,"zip":49,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Central People's Hospital of Zhanjiang","RECRUITING","Zhanjiang","Guangdong","China","CN",{"type":78,"coordinates":79},"Point",[80,81],110.38749,21.23391,{"lat":81,"lon":80},[84],{"name":85,"role":62,"phone":86,"phoneExt":49,"email":49},"Xingyue Song","18040520787",{"facility":88,"status":89,"city":90,"state":91,"zip":49,"country":75,"countryCode":76,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Tongji Medical College, Huazhong University of Science and Technology","NOT_YET_RECRUITING","Wuhan","Hubei",{"type":78,"coordinates":93},[94,95],114.26667,30.58333,{"lat":95,"lon":94},[98,101,103],{"name":99,"role":62,"phone":100,"phoneExt":49,"email":49},"Yuwei Lai","13247125977",{"name":102,"role":57,"phone":49,"phoneExt":49,"email":49},"Gang Liu",{"name":104,"role":57,"phone":49,"phoneExt":49,"email":49},"An Pan",{"type":57,"investigatorFullName":104,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Professor","100558638","effects-of-vitamin-d-and-prebiotic-supplementation-on-glucose-control-during-pregnancy-100558638",false,"NCT06553729","Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy","Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n1. 6-15 weeks of gestation.\n2. Age 18-45 years old.\n3. Permanent resident or resident locally at least one year.\n4. GDM high-risk pregnant women (meeting any of the following criteria):\n\n   1. Pre-pregnancy body mass index (BMI) ≥24.0 kg\u002Fm2,\n   2. History of GDM or a family history of diabetes,\n   3. History of delivery of macrosomia (birth weight \\>4000 g),\n   4. HbA1c 5.7-6.4% or fasting blood glucose 5.6-7.0 mmol\u002FL.\n\nExclusion Criteria:\n\n1. Multiple pregnancy.\n2. Have received infertility treatment such as in vitro fertilization or intrauterine insemination.\n3. History of diabetes or current diagnosis of diabetes (including type 1 and type 2 diabetes) or abnormal glucose tolerance at recruitment (fasting blood glucose \\>7.0 mmol\u002FL or HbA1c≥6.5%).\n4. Serious chronic diseases (including cardiovascular and cerebrovascular diseases, cancer, and thyroid dysfunction) or infectious diseases (including hepatitis B, active tuberculosis, acquired immunodeficiency syndrome, and syphilis).\n5. Severe liver disease (such as cirrhosis) or severe kidney disease (such as renal failure or requiring dialysis).\n6. Kidney stones, hypercalcemia, hypercalciuria, parathyroid hormone abnormality.\n7. Any mental disorders, such as schizophrenia, depression, other mental disorders, or bipolar disorder.\n8. History of allergy or intolerance to vitamin D, chicory root, or starch.\n9. Have participated in or are participating in other clinical trials within the past 3 months.\n10. Daily vitamin D intake \\>800 IU.\n11. Inability or refusal to answer and communicate.\n12. Those who are unwilling to sign the informed consent.\n13. The researcher thinks that it is not suitable to participate in this research.","FEMALE","18 Years","45 Years",{"count":118,"type":119},500,"ESTIMATED","INTERVENTIONAL",[122],"NA","The goal of this randomized, double-blind, placebo-controlled study included pregnant women at high risk of GDM at 6-15 weeks of gestation is to investigate whether supplementation with vitamin D (1600 IU per day) or prebiotics (inulin, 10 gram per day) during pregnancy has beneficial effects on controlling blood glucose during pregnancy.",[125],"Glucose Intolerance During Pregnancy",[127,40,125,128,129,130],"Vitamin D","Blood Glucose","Gestation diabetes","Adverse pregnancy outcomes","2025-09-10",{"date":133,"type":134},"2025-09-16","ACTUAL",{"date":136,"type":134},"2025-02-24",{"date":138,"type":119},"2026-12-31",{"name":5,"class":6},2]