EUCTR2016-002460-13-ATActive, not recruitingPhase 1
Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency: a multicenter, placebo-controlled double-blind phase III RCT - VITDALIZE
Medical University of Graz0 sites2,400 target enrollmentStarted: November 15, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 2,400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Age =18 years
- •2.Expected primary ICU stay = 48 hours
- •3.= 72 hours in primary ICU at screening blood sample
- •4.Severe vitamin D deficiency (=12 ng/ml or undetectable)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1200
Exclusion Criteria
- •1.Hypercalcemia at inclusion (total Ca > 2.65 mmol/l, ionized Ca > 1.35 mmol/l)
- •2.Study medication intake not possible (mask, ileus, residual volume high)
- •3.History of kidney stones (= 1 year)
- •4.Granulomatous disease (active tuberculosis or sarcoidosis)
- •5.Pregnant/nursing
- •6.Other reasons* (DNR= do not resuscitate, relevant psychiatric disease, prisoner)
- •7.Hypersensitivity to drug or excipient
Investigators
Similar Trials
Active, not recruiting
Not Applicable
VITDALIZE UK: Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiencyNutritional, Metabolic, EndocrineVitamin D deficiencyISRCTN44822292Medical University of Graz2,400
Active, not recruiting
Phase 1
K Arm of the Effect of High-Dose Vitamin D3 on 28-Day Mortality in Adult Critically Ill Patients with Severe Vitamin D Deficiency.Critically ill patients who are in intensive care and are found to be severely vitamin D deficient (25(OH)D =12ng/ml (30nmol/L)).MedDRA version: 21.1Level: PTClassification code 10059936Term: Blood 25-hydroxycholecalciferolSystem Organ Class: 10022891 - InvestigationsMedDRA version: 21.1Level: PTClassification code 10053813Term: Blood 25-hydroxycholecalciferol decreasedSystem Organ Class: 10022891 - InvestigationsMedDRA version: 21.0Level: LLTClassification code 10080368Term: Vitamin D3 deficiencySystem Organ Class: 100000004861MedDRA version: 20.0Level: PTClassification code 10077264Term: Critical illnessSystem Organ Class: 10018065 - General disorders and administration site conditionsEUCTR2016-002460-13-GBMedical Unviersity of Graz2,400
Completed
Not Applicable
Effect of high dose Vitmin D on mortality and morbidity in pulmonary ICU patients.Respiratory faillure.Respiratory failure, not elsewhere classifiedIRCT2014050517583N1Research deputy of Tabriz University of Medical Sciences40
Active, not recruiting
Phase 1
THE IMPACT OF VITAMIN D3 HIGH DOSES SUPPLEMENTATTION ON SOFT TISSUE WOUND-HEALING AFTER MANDIBULAR THIRD MOLAR (M3) REMOVAL: A PILOT STUDYVitamin D insufficiency undergoing tooth extractionEUCTR2021-000200-38-ATniversity Clinic of Dentistry, Medical University of Vienna20
Recruiting
Phase 3
The VITDALIZE Study:Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency: a multicenter, placebo-controlled double-blind phase III RCTE55.9Vitamin D deficiency, unspecifiedDRKS00016940niversitätsklinikum Würzburg (Sponsor in Deutschland)800