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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01130181

Acronym

VITdAL@ICU

Enrollment

480

Registered

2010-05-25

Start date

2010-05-31

Completion date

2012-09-30

Last updated

2014-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Vitamin D Deficiency

Brief summary

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.

Detailed 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

Interventions

DRUGCholecalciferol

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

DRUGPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Length of hospital stay	maximum 6 months	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.

Secondary

Measure	Time frame	Description
25(OH)D levels	maximum 6 months	serum 25(OH)D levels will be measured on day 0, 3 and 7
calcium levels	maximum 6 months	serum calcium levels will be measured on day 0, 3 and 7
length of ICU stay starting from application of study medication	until patient's death or referral to another ward	—
duration of mechanical ventilation	starting from application of study medication	duration of mechanical ventilation including CPAP/mask ventilation
hospital mortality, 28-day mortality, 6 month-mortality	maximum 6 months	—

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026