Overview

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
0
Participant gender:
All
Summary
In the VITdAL-ICU trial using a large oral dose of vitamin D3 in 480 adult critically ill patients, there was no benefit regarding the primary endpoint hospital length of stay. However, the predefined subgroup with severe vitamin D deficiency (25(OH)D ≤ 12ng/ml) had significantly lower 28-day mortality (36.3% placebo vs. 20.4% vitamin D group, hazard ratio (HR) 0.52 (0.30-0.89), number needed to treat = 6). Therefore, high-dose vitamin D3 in a population of severely vitamin D deficient critically ill patients is a promising and inexpensive intervention that requires confirmatory multicenter studies. To date, only 7 interventions (e.g. noninvasive ventilation or prone positioning) have ever demonstrated mortality benefit for Intensive Care Unit (ICU) patients in multicenter trials. In case of benefit, vitamin D treatment in critically ill patients could be immediately implemented worldwide.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of Graz
Collaborators:
Barmherzige Brüder Vienna
Centre Hospitalier Régional de la Citadelle
Centre Hospitalier Universitaire de Charleroi
Centre Hospitalier Universitaire Mons
Erasme University Hospital
Hospital Barmherzige Brüder St. Veit
Johannes Kepler University of Linz
KABEG Management
Kages
Klinikum Klagenfurt am Wörthersee
Krankenhaus Barmherzige Schwestern Linz
Medical University Innsbruck
Medical University of Vienna
University Hospital, Frankfurt
University of Birmingham
Wuerzburg University Hospital
Treatments:
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Criteria
Inclusion Criteria:

- ≥18 years

- Anticipated ICU stay ≥ 48 hours

- Admission to ICU ≤ 72 hours before screening

- Severe vitamin D deficiency (≤12 ng/ml or undetectable)

Exclusion Criteria:

- Severe gastrointestinal dysfunction (> 400 ml residual volume)/unable to take study
medication

- Do not resuscitate (DNR) order/imminent death

- hypercalcemia

- known recent nephrolithiasis, active tuberculosis or sarcoidosis

- pregnancy/lactation

- not deemed appropriate by study team/physician