Study hypothesis: High-dose vitamin D leads to a shorter hospital stay in critically ill patients Vitamin D deficient patients will be randomized to receive either 540,000 IU cholecalciferol or placebo.
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 * hypercalcaemia (total calcium \>2.65 OR ion. calcium \>1.35 mmol/l) * severely impaired gastrointestinal motility (ileus, residual gastric volume \> 400 ml) * known history of recent kidney stones (≤ 1 year) * known granulomatous diseases (tuberculosis, sarcoidosis) * pregnancy Primary endpoint * hospital stay (hours; starting from ICU admission) Secondary endpoints * percentage of patients with 25(OH)D ≥ 30 ng/ml at day 7 * serum calcium; phosphorus; 25(OH)D; 1,25(OH)D; PTH; osteocalcin; bALP; TRAP; urinary calcium
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
480
loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU
Matching placebo
Medical University of Graz
Graz, Austria
Length of hospital stay
The length of hospital stay will be compared between the two groups (starting from application of the study medication; end is defined as death of the patient or hospital discharge) Survivors and non-survivors will also be analysed separately. Stay in rehabilitation facilities will not be counted.
Time frame: maximum 6 months
25(OH)D levels
serum 25(OH)D levels will be measured on day 0, 3 and 7
Time frame: maximum 6 months
calcium levels
serum calcium levels will be measured on day 0, 3 and 7
Time frame: maximum 6 months
length of ICU stay starting from application of study medication
Time frame: until patient's death or referral to another ward
duration of mechanical ventilation
duration of mechanical ventilation including CPAP/mask ventilation
Time frame: starting from application of study medication
hospital mortality, 28-day mortality, 6 month-mortality
Time frame: maximum 6 months
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