High-dose Vitamin D3 for critically ill patients
The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients With Severe Vitamin D Deficiency: a Multicenter, Placebo-controlled Double-blind Phase III Randomized Controlled Trial (RCT)
This study is testing if giving high doses of vitamin D3 can help critically ill adults with severe vitamin D deficiency live longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2400 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 18 sites (Enzenbach and 17 other locations) |
| Trial ID | NCT03188796 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of high-dose vitamin D3 on 28-day mortality in adult patients who are critically ill and have severe vitamin D deficiency. It is a multicenter, placebo-controlled, double-blind randomized controlled trial involving 480 participants who will be randomly assigned to receive either vitamin D3 or a placebo. The study aims to confirm previous findings that suggested a significant reduction in mortality among severely vitamin D deficient patients. The results could provide insights into a low-cost intervention for improving outcomes in critically ill patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are critically ill, have a severe vitamin D deficiency, and are expected to stay in the ICU for at least 48 hours.
Not a fit: Patients with severe gastrointestinal dysfunction, those with a do-not-resuscitate order, or those with conditions like hypercalcemia or active tuberculosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality rates in critically ill patients with severe vitamin D deficiency.
How similar studies have performed: Previous studies have shown promising results with vitamin D supplementation in critically ill patients, but this specific approach is being further validated in a larger multicenter setting.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Enzenbach and 17 other locations
- LKH Enzenbach — Enzenbach, Austria (Recruiting)
- LKH Feldbach — Feldbach, Austria (Terminated)
- Medical University of Graz — Graz, Austria (Recruiting)
- Klinikum am Wörthersee — Klagenfurt, Austria (Recruiting)
- LKH Hochsteiermark Standort Leoben — Leoben, Austria (Recruiting)
- Barmherzige Schwestern — Linz, Austria (Recruiting)
- Kepler Universitätsklinikum Linz — Linz, Austria (Recruiting)
- Krankenhaus Schwarzach — Schwarzach im Pongau, Austria (Terminated)
- Barmherzige Brüder — Vienna, Austria (Recruiting)
- Kaiser Franz Josef Spital Wien — Vienna, Austria (Suspended)
- Medical University of Vienna — Vienna, Austria (Recruiting)
- LKH Villach — Villach, Austria (Recruiting)
- Erasme Hospital — Brussels, Belgium (Terminated)
- CHU de Charleroi — Charleroi, Belgium (Terminated)
- CHR Citadelle — Liège, Belgium (Terminated)
- CHU Ambroise Pare — Mons, Belgium (Terminated)
- University Hospital Wuerzburg — Würzburg, Germany (Recruiting)
- University of Birmingham — Birmingham, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Karin Amrein, MD, MSc — Medical University of Graz
- Study coordinator: Karin Amrein, MD, MSc
- Email: karin.amrein@medunigraz.at
- Phone: +43 681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.