VITDAL@ICU (Pilot Study) - Vitamin D supplementation in critically ill patients – prospective, double-blind, randomized, placebo-controlled trial
Phase 2
- Conditions
- Critically ill patientsVitamin D deficiencyE55
- Registration Number
- DRKS00000750
- Lead Sponsor
- Medical University Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Age =18 years
- expected ICU stay = 48 hours
- vitamin D deficiency: 25(OH)D = 20 ng/ml
- feasibility of study drug application via nasogastric tube in cases where
oral food intake is not possible
Exclusion Criteria
- moribund patient expected to die within 24 hours
- admission diagnosis septic shock”
- hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l)
- severely impaired gastrointestinal motility (ileus, necessitating nasogastric
suction tube)
- known history of recent kidney stones (= 1 year)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with 25(OH)D = 30 ng/ml at day 7
- Secondary Outcome Measures
Name Time Method ab analysis:<br>Calcium, phosphorus, 25(OH)D, 1,25(OH)D, PTH, osteocalcin, bALP, TRAP, NT-proBNP levels, urinary calcium at days 0,1,2,3,7,28 (if feasable); <br>hospital and ICU stay; <br>duration of mechanical ventilation; <br>hospital mortality