[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511311":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":41,"centralContacts":46,"locations":52,"responsibleParty":68,"collaborators":41,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":41,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":41,"enrollmentInfo":79,"targetDuration":41,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":54,"whyStopped":41,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,14,18,22,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Control1","PLACEBO_COMPARATOR","Participants with serum 25(OH)D levels of 15-19.9 ng\u002FmL, receiving 40 cc. medium-chain triglyceride (MCT) supplement.",[13],"Dietary Supplement: Medium Chain Triglycerides (MCT)",{"label":15,"type":10,"description":16,"interventionNames":17},"Control2","Participants with serum 25(OH)D levels of 12-14.9 ng\u002FmL, receiving 50 cc. MCT supplement.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Control3","Participants with serum 25(OH)D levels below 12 ng\u002FmL, receiving 60 cc. MCT supplement.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Vitamin D1","EXPERIMENTAL","Participants with serum 25(OH)D levels of 15-19.9 ng\u002FmL, receiving vitamin D3 of 576,000 IU supplement",[27],"Dietary Supplement: Vitamin D3",{"label":29,"type":24,"description":30,"interventionNames":31},"Vitamin D2","Participants with serum 25(OH)D levels of 12-14.9 ng\u002FmL, receiving vitamin D3 of 720,000 IU supplement",[27],{"label":33,"type":24,"description":34,"interventionNames":35},"Vitamin D3","Participants with serum 25(OH)D levels below 12 ng\u002FmL, receiving vitamin D3 of 864,000 IU supplement",[27],[37,42],{"type":38,"name":33,"description":39,"armGroupLabels":40,"otherNames":41},"DIETARY_SUPPLEMENT","Dose of vitamin D3 depends on participant's serum 25(OH)D levels, with one sample bottle contains 72,000 IU of vitamin D3; Intervention starts on ICU day 3 with a frequency of 1 ampule every 3 hours and is completed within the following 48 hours",[23,29,33],null,{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Medium Chain Triglycerides (MCT)","Dose of MCT depends on participant's serum 25(OH)D levels, with one sample bottle contains 5 cc. of MCT; Intervention starts on ICU day 3 with a frequency of 1 ampule every 3 hours and is completed within the following 48 hours",[9,15,19],[47],{"name":48,"role":49,"phone":50,"phoneExt":41,"email":51},"Yin Yi Han, doctor","CONTACT","886972651405","noviahan@gmail.com",[53],{"facility":5,"status":54,"city":55,"state":41,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Taipei","100","Taiwan","TW",{"type":60,"coordinates":61},"Point",[62,63],121.52639,25.05306,{"lat":63,"lon":62},[66],{"name":67,"role":49,"phone":50,"phoneExt":41,"email":51},"Yin-Yi Han, doctor",{"type":69,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100511311","early-vitamin-d3-supplementation-for-critically-ill-patients-100511311",false,"NCT05937789","Early Vitamin D3 Supplementation for Critically Ill Patients","Effects of Early Vitamin D3 Supplementation on Clinical Outcomes for Critically Ill Patients","Inclusion Criteria:\n\n* ≥18-year-old critically ill patient.\n* ICU admission \\\u003C 24 hours.\n* Baseline 25(OH)D levels within 24 hours of ICU admission \\\u003C 20 ng\u002FmL.\n* Expected ICU length of stay ≥ 72 hours.\n\nExclusion Criteria:\n\n* Hypercalcemia (ie. total serum calcium levels \\> 2.6 mmol\u002FL).\n* Disorders affecting serum 25(OH)D levels, calcium metabolism, or bone metabolism (eg, parathyroid disease, rickets, or severe cirrhosis \\[Child C\\]).\n* Having received high-dose vitamin D3 therapy (ie. \\> 2,000 IU daily or a single dose of ≥ 10,000 IU) within the past four weeks.\n* Active COVID-19 at ICU admission.\n* Organ transplant.\n* Having had tuberculosis, sarcoidosis or kidney stones within the past year.\n* Having renal dialysis, continuous kidney replacement therapy (CKRT), acute kidney injury (AKI).\n* Having ICU admission within the past three months.\n* Non-native-speaking patients and their families\n* Pregnant women.","ALL","18 Years",{"count":80,"type":81},240,"ESTIMATED","INTERVENTIONAL",[84],"NA","There are no clear international guidelines for dosing vitamin D based on deficiency severity. Therefore, a new clinical trial is needed to evaluate the benefits of early vitamin D supplementation in maintaining sufficient levels for critically ill patients. The investigators conducted a multicenter clinical trial in Taiwan focusing on vitamin D and critically ill patients. 240 patients with low calcidiol levels will be enrolled and be provided varying supplementation doses to maintain their serum calcidiol levels ≥ 30 ng\u002FmL within 30 days of ICU admission. The serum levels of calcidiol and PTH will be measured on Day 0, Day 7, Day 14 and Day 30 before and after vitamin D supplementation. The results will serve as a valuable reference for intensivists when formulating appropriate vitamin D treatment strategy to maximize clinical benefits for critically ill patients.",[87,88],"Vitamin D Deficiency","Critical Illness",[90,91,92],"vitamin D","calcidiol levels","critically ill","2024-08-14",{"date":95,"type":96},"2024-08-16","ACTUAL",{"date":98,"type":96},"2024-01-22",{"date":100,"type":81},"2026-12-31",{"name":5,"class":6},1]