VITdAL@ICU - Correction of Vitamin D Deficiency in Critically Ill Patients (VITdAL@ICU)

Correction of Vitamin D Deficiency in Critically Ill Patients: a Randomized, Double-blind, Placebo-controlled Trial ("VITDAL@ICU")

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

loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU

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.

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

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