Actively Recruiting
The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
Led by Medical University of Graz · Updated on 2025-11-21
2400
Participants Needed
18
Research Sites
489 weeks
Total Duration
On this page
Sponsors
M
Medical University of Graz
Lead Sponsor
M
Medical University of Vienna
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Anticipated ICU stay of at least 48 hours
- Admission to ICU within 72 hours before screening
- Severe vitamin D deficiency (levels 12 ng/ml or less, or undetectable)
You will not qualify if you...
- Severe gastrointestinal dysfunction preventing medication intake (residual volume over 400 ml)
- Do not resuscitate (DNR) order or expected imminent death
- Hypercalcemia
- Recent kidney stones, active tuberculosis, or sarcoidosis
- Pregnancy or breastfeeding
- Considered inappropriate for the study by the medical team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
LKH Enzenbach
Enzenbach, Austria
Actively Recruiting
2
LKH Feldbach
Feldbach, Austria
Terminated
3
Medical University of Graz
Graz, Austria
Actively Recruiting
4
Klinikum am Wörthersee
Klagenfurt, Austria
Actively Recruiting
5
LKH Hochsteiermark Standort Leoben
Leoben, Austria
Actively Recruiting
6
Barmherzige Schwestern
Linz, Austria
Actively Recruiting
7
Kepler Universitätsklinikum Linz
Linz, Austria
Actively Recruiting
8
Krankenhaus Schwarzach
Schwarzach im Pongau, Austria
Terminated
9
Barmherzige Brüder
Vienna, Austria
Actively Recruiting
10
Kaiser Franz Josef Spital Wien
Vienna, Austria
Suspended
11
Medical University of Vienna
Vienna, Austria
Actively Recruiting
12
LKH Villach
Villach, Austria
Actively Recruiting
13
Erasme Hospital
Brussels, Belgium
Terminated
14
CHU de Charleroi
Charleroi, Belgium
Terminated
15
CHR Citadelle
Liège, Belgium
Terminated
16
CHU Ambroise Pare
Mons, Belgium
Terminated
17
University Hospital Wuerzburg
Würzburg, Germany
Actively Recruiting
18
University of Birmingham
Birmingham, United Kingdom
Actively Recruiting
Research Team
K
Karin Amrein, MD, MSc
CONTACT
A
Astrid Friedel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here