[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644494":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":26,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Chulalongkorn University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vitamin D2 Monotherapy","ACTIVE_COMPARATOR","Participants in this arm will receive vitamin D2 40,000 IU orally once weekly for 3 months. At month 3, participants whose 25-hydroxyvitamin D level remains below 20 ng\u002FmL may receive treatment adjustment according to the study protocol.",[13],"Drug: Vitamin D2",{"label":15,"type":16,"description":17,"interventionNames":18},"Vitamin D2 Plus Calcitriol","EXPERIMENTAL","Participants in this arm will receive vitamin D2 40,000 IU orally once weekly plus calcitriol 50 ng\u002Fkg\u002Fday orally for 3 months. At month 3, participants whose 25-hydroxyvitamin D level remains below 20 ng\u002FmL may receive treatment adjustment according to the study protocol.",[13,19],"Drug: Calcitriol",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Vitamin D2","Vitamin D2 40,000 IU\u002Fweek weekly",[9,15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Calcitriol","Calcitriol 50 ng\u002Fkg\u002Fday once daily",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"THANAPORN NiLYAEM","CONTACT","66852811244","namobnamob@docchula.com",[38],{"facility":39,"status":40,"city":41,"state":26,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"King Chulalongkorn Memorial Hospital","RECRUITING","Bangkok","10330","Thailand","TH",{"type":46,"coordinates":47},"Point",[48,49],100.50144,13.75398,{"lat":49,"lon":48},[52],{"name":39,"role":34,"phone":53,"phoneExt":26,"email":54},"6622564493","research@chula.ac.th",{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100644494","phase-4-vitamin-d2-versus-vitamin-d2-plus-calcitriol-in-cholestatic-children-with-vitamin-d-deficiency-100644494",false,"NCT07670611","VITAMIN D2 VERSUS VITAMIN D2 PLUS CALCITRIOL IN CHOLESTATIC CHILDREN WITH VITAMIN D DEFICIENCY","ACCELERATED CORRECTION OF VITAMIN D DEFICIENCY IN CHOLESTATIC CHILDREN: A COMPARATIVE TRIAL OF VITAMIN D2 MONOTHERAPY VERSUS COMBINATION THERAPY WITH CALCITRIOL","VITD-CHOL","Inclusion Criteria:\n\n* Patients younger than 18 years of age.\n* Patients diagnosed with cholestasis, defined as direct\u002Fconjugated bilirubin \\>1 mg\u002FdL for more than 1 month.\n* Patients diagnosed with chronic liver disease.\n* Patients with vitamin D deficiency, defined as serum 25-hydroxyvitamin D (25-OHD) level \\\u003C20 ng\u002FmL, according to the Endocrine Society Clinical Practice Guideline.\n\nExclusion Criteria:\n\n* Pre-existing hypercalciuria, screened by urine calcium testing before enrollment.\n* Patients with benign or malignant tumors.\n* Patients with renal tubular defects, screened by electrolyte testing before enrollment.\n* Patients currently receiving anticonvulsant therapy.\n* Patients who do not attend scheduled follow-up visits.","ALL","18 Years",{"count":68,"type":69},54,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","The goal of this clinical trial is to learn whether adding calcitriol to vitamin D2 can improve vitamin D deficiency in children with cholestasis and chronic liver disease. Cholestasis is a condition in which bile flow is reduced, which can make it difficult for the body to absorb and process vitamin D. The study will also learn about the safety of using vitamin D2 together with calcitriol.\n\nThe main questions it aims to answer are:\n\n* Does vitamin D2 plus calcitriol increase blood 25-hydroxyvitamin D (25-OHD) levels more than vitamin D2 alone after 3 months of treatment?\n* Does vitamin D2 plus calcitriol help more children reach an adequate vitamin D level by 3 and 6 months?\n* What medical problems, especially high calcium or high phosphorus levels, occur during treatment?\n\nResearchers will compare children who receive vitamin D2 alone with children who receive vitamin D2 plus calcitriol to see which treatment improves vitamin D levels more effectively and safely.\n\nParticipants will:\n\n* Take vitamin D2 alone or vitamin D2 plus calcitriol as assigned by randomization\n* Visit the clinic for study assessments at the start of the study, at 3 months, and at 6 months\n* Have blood tests to measure vitamin D levels, calcium, phosphorus, parathyroid hormone, liver function, and other safety markers\n* Have their treatment reviewed at 3 months; participants whose vitamin D level remains low may have their treatment adjusted according to the study plan\n* Bring back medication packages so researchers can check how regularly the study medicines were taken",[75,76,77,78],"Cholestatic Liver Disease","Chronic Liver Disease (CLD)","Vitamin D Deficiency","Children",[80,81,82,28,83],"cholestasis","pediatrics","vitamin d deficiency","25-Hydroxyvitamin D2","2026-06-22",{"date":86,"type":87},"2026-06-26","ACTUAL",{"date":89,"type":87},"2026-04-28",{"date":91,"type":69},"2027-04-20",{"name":5,"class":6},1]