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

Harald Dobnig, MD

Status and phase

Completed

Phase 3

Conditions

Vitamin D Deficiency

Critical Illness

Treatments

Drug: Cholecalciferol

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

VITdAL@ICU - 19022010

Details and patient eligibility

About

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.

Full description

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

Enrollment

480 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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