[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100268864":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":18,"responsibleParty":33,"collaborators":18,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":18,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":60,"whyStopped":18,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":18},{"fullName":5,"class":6},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vitamin D","EXPERIMENTAL","Drug: Vitamin D3 800 IU daily besides the anti-virus treatment with nucleos(t)ide medicine",[13],"Drug: Vitamin D3",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","chronic hepatitis B patients with long term anti-virus therapy",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Vitamin D3","Participants with chronic hepatitis B will take 800 IU of vitamin D3 per day by mouth besides the anti-virus treatment with nucleos(t)ide medicine",[9],[26],{"name":27,"affiliation":5,"role":28},"Yutian Chong, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":27,"role":31,"phone":18,"phoneExt":18,"email":32},"CONTACT","ytchongkyzy@126.com",{"type":28,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Yutian Chong","Professor","100268864","phase-4-oral-vitamin-d-treatment-for-the-prevention-of-hepatocellular-carcinoma-100268864",false,"NCT02779465","Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma","Study of Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B","VDHCC","Inclusion Criteria:\n\n* All subjects between the ages of 18 and 70 with chronic hepatitis B and under the oral anti-virus treatment followed at the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, will be offered entry into this study. The diagnosis of chronic Hepatitis B will be based on that they had been positive for hepatitis B surface antigen (HBsAg) for at least six months, and were positive for HBeAg or negative for HBeAg with detectable HBV DNA at screening.\n* No evidence of HCC on entry imaging study.\n* Model for End Stage Liver Disease (MELD) score under 22 (a MELD score over 22 would predict a 3 month mortality rate of approximately 20%).\n* Not currently participating in another intervention study.\n* Not pregnant or lactating, and willing to use effective contraception during study period.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n* Ability to provide written informed consent according to national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* evidence of hepatocellular carcinoma within 6 months after enrollment,\n* a serum alanine aminotransferase level more than 10 times the upper limit of normal,\n* an elevated serum creatinine level,\n* any diagnosis of kidney stones,\n* a diagnosis of hyperparathyroidism or other serious disturbance of calcium metabolism in the past 5 years,\n* any evidence of autoimmune hepatitis, coinfection with hepatitis C or D virus or human immunodeficiency virus,\n* other serious concurrent illness (e.g., alcoholism, uncontrolled diabetes, or cancer),\n* treatment with immunomodulatory within the 6 months before screening,\n* treatment with any investigational drug within the 30 days before the study began.","ALL","18 Years","70 Years",{"count":48,"type":49},1500,"ESTIMATED","INTERVENTIONAL",[52],"PHASE4","The purpose of this study is to determine whether vitamin D is effective in the prevention of hepatocellular carcinoma in those patients with chronic hepatitis B.",[55,56],"Hepatitis B","Carcinoma, Hepatocellular",[58,59],"vitamin D treatment","chronic hepatitis B","NOT_YET_RECRUITING","2016-05-19",{"date":63,"type":49},"2016-05-20",{"date":65,"type":18},"2016-06",{"date":67,"type":49},"2026-12",{"name":5,"class":6}]