[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642298":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":45,"collaborators":18,"id":47,"slug":18,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":18,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":18,"enrollmentInfo":56,"targetDuration":18,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"calcium + vitamin D group","EXPERIMENTAL","Intervention for epilepsy patients",[13],"Drug: Supplementation with calcium + vitamin D daily.",{"label":15,"type":16,"description":17,"interventionNames":18},"standard of care group","NO_INTERVENTION","Epilepsy patients receive normal follow-up without any intervention.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Supplementation with calcium + vitamin D daily.","Test bone metabolism indicators at 10-14 weeks of pregnancy and intervene based on vitamin D levels.\n\n* For vitamin D levels \\> 20 ng\u002Fml: Supplementation with 725 mg of calcium + 500 IU of vitamin D daily.\n* For 10 ng\u002Fml \\\u003C vitamin D levels ≤20 ng\u002Fml: Supplementation with 725 mg of calcium + 900 IU of vitamin D daily.\n* For vitamin D levels ≤10 ng\u002Fml: Supplementation with 725 mg of calcium + 1300 IU of vitamin D daily.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Jiajia Fang","CONTACT","15215880868","fangjjiaj@zju.edu.cn",[32],{"facility":5,"status":33,"city":34,"state":18,"zip":18,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Zhejiang","China","CN",{"type":38,"coordinates":39},"Point",[40,41],105.583,25.3238,{"lat":41,"lon":40},[44],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"type":46,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100642298",false,"NCT07651709","Bone Management in Pregnancy Outcomes in Epilepsy","Bone Health Management on Pregnancy Outcomes in Women With Epilepsy: Randomized Study","Inclusion Criteria:\n\n* Diagnosis of focal or generalized epilepsy as defined by the International League Against Epilepsy.\n* Women of childbearing age, aged ≥18 years, planning pregnancy or in early pregnancy (≤16 weeks gestation, confirmed by last menstrual period or ultrasound) - single pregnancy.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Pre-existing conditions affecting bone metabolism: primary hyperparathyroidism, Paget's disease, multiple myeloma, chronic kidney disease (eGFR \\\u003C60 mL\u002Fmin), cirrhosis (Child-Pugh B\u002FC), or untreated hyper\u002Fhypothyroidism.\n* History of metabolic complications: hypercalcemia (serum Ca²⁺ \\>10.5 mg\u002FdL), nephrolithiasis, or granulomatous diseases.\n* Recent\u002Fcurrent use of bone-modifying drugs: bisphosphonates, glucocorticoids (≥5 mg\u002Fday prednisone equivalent for \\>1 month), or loop diuretics within the past year.\n* Ultrasound shows fetal malformation.\n* Presence of other severe systemic diseases deemed unsuitable for study participation by the investigator.",true,"FEMALE","18 Years",{"count":57,"type":58},80,"ESTIMATED","INTERVENTIONAL",[61],"NA","This study is aimed to evaluate the efficacy of bone health management in improving pregnancy outcomes among WWE, and establish evidence-based vitamin D supplementation strategies for childbearing-age WWE.",[64,65,66],"Epilepsy","Pregnant Woman","Bone Health",[68,69],"epilepsy","pregnancy","2026-06-11",{"date":72,"type":73},"2026-06-16","ACTUAL",{"date":75,"type":58},"2026-06",{"date":77,"type":58},"2035-01",{"name":5,"class":6},1]