[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559992":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":33,"overallOfficials":39,"centralContacts":43,"locations":51,"responsibleParty":70,"collaborators":13,"id":72,"slug":13,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":13,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":13,"enrollmentInfo":79,"targetDuration":13,"studyType":82,"phases":13,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":53,"whyStopped":13,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Medical University of Gdansk","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"efficacy and safety of cholecalciferol therapy in dialysed patients","analysis of - vitamin D levels - 25(OH)D, 1,25(OH)2D, calcium-phosphate metabolism parameters (serum calcium, phosphate, PTH levels),FGF23, GDF15 levels, in 3 groups of patients achieving different range of 25(OH)D levels","2022-2026",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"CASE_CONTROL","PROSPECTIVE","The analysis will involve data obtained from medical records of dialysis patients who receive standard procedures consistent with national and international guidelines for specialized care.\n\nSpecifically, we will analyze the levels of:\n\n* 25(OH)D,\n* 1,25(OH)2D\n* Calcium\n* Phosphates\n* PTH\n* FGF23\n* GDF15 to assess the efficacy and safety of cholecalciferol in dialysis patients.","Patients will be recruited in Department of Nephrology Transplantology and Internal Medicine, Medical University of Gdansk",[20,25,29],{"label":21,"type":13,"description":22,"interventionNames":23},"25(OH)D \u003C 30 ng\u002FmL","Dialysed patients with vitamin D level (25(OH)D) \\\u003C 30 ng\u002FmL administered cholecalciferol",[24],"Drug: Cholecalciferol",{"label":26,"type":13,"description":27,"interventionNames":28},"25(OH)D 30 - 49.9 ng\u002FmL","Dialysed patients with vitamin D level (25(OH)D) 30-49.9 ng\u002FmL administered cholecalciferol",[24],{"label":30,"type":13,"description":31,"interventionNames":32},"25(OH)D 50-80 ng\u002FmL","Dialysed patients with vitamin D level (25(OH)D) 50-80 ng\u002FmL administered cholecalciferol",[24],[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":13},"DRUG","Cholecalciferol","The patients with vitamin D (25(OH)D) levels \\\u003C 30 ng\u002FmL, and 30-50 ng\u002Fml will recieve a dose of cholecalciferol at 70,000 IU per week (20,000 IU + 20,000 IU + 30,000 IU per week).\n\nIn the patients with 25(OH)D levels 50-80 ng\u002FmL the dose of cholecalciferol will be adjusted to avoid exceeding the upper limit of the laboratory norm.",[26,30,21],[40],{"name":41,"affiliation":5,"role":42},"Leszek Tylicki, Prof.","PRINCIPAL_INVESTIGATOR",[44,48],{"name":41,"role":45,"phone":46,"phoneExt":13,"email":47},"CONTACT","+ 48 58 584 47 00","leszek.tylicki@gumed.edu.pl",{"name":49,"role":45,"phone":13,"phoneExt":13,"email":50},"Agnieszka Tarasewicz, MD; PhD","ataras@gumed.edu.pl",[52],{"facility":5,"status":53,"city":54,"state":13,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Gdansk","80-211","Poland","PL",{"type":59,"coordinates":60},"Point",[61,62],18.64912,54.35227,{"lat":62,"lon":61},[65,68],{"name":66,"role":45,"phone":67,"phoneExt":13,"email":47},"Tylcki Leszek, Prof.","+48 58 584 47 07",{"name":69,"role":45,"phone":67,"phoneExt":13,"email":50},"Agnieszka Tarasewicz, Md, PhD",{"type":71,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100559992",false,"NCT06571344","Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management","Inclusion Criteria:\n\n* CKD stage 5,dialysed patients with vitamin D deficiency or insufficiency (level of 25(OH)D \\\u003C 30 ng\u002FmL)\n\nExclusion Criteria:\n\n* dialysis time of less than 3 months\n* inadequately controled secondary hyperparathyroidism (iPTH\\>800pg\u002FmL)\n* treatment with calcimimetics\n* treatment with active forms of vitamin D3,\n* parathyroidectomy\n* bilateral nephrectomy\n* treatment with corticosteroids\n* lack of consent to take part in the study.","ALL","18 Years",{"count":80,"type":81},160,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the effects of cholecalciferol administration, according to guidelines for the general population, on laboratory parameters of Chronic Kidney Disease-Mineral and Bone Disorder in dialysis patients, depending of the attained levels of vitamin D (25OH)D).\n\nThe main question it aims to answer is:\n\nHow does cholecalciferol affect calcium and phosphate metabolism parameters depending on the achieved levels of 25(OH)D?\n\nParticipants taking cholecalciferol as part of their regular medical care for CKD-MBD will have the laboratory result parameters observed for up to 4 years.",[85],"Vitamin D Deficiency Due to Chronic Kidney Disease",[87,88,89,90,91,92,93,94],"vitamin D","cholecalciferol","25-hydroxycholecalciferol","parathyroid hormone","FGF23","GDF15","chronic kidney disease-mineral and bone disorder","dialysis","2024-08-23",{"date":97,"type":98},"2024-08-26","ACTUAL",{"date":100,"type":98},"2022-11-01",{"date":102,"type":81},"2026-12-31",{"name":5,"class":6},1]