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

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

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