RecruitingPhase 3NCT03188796

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


Sponsor

Medical University of Graz

Enrollment

2,400 participants

Start Date

Oct 10, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving a high dose of vitamin D3 to critically ill patients in the ICU who have severe vitamin D deficiency improves their chance of survival at 28 days. Vitamin D deficiency is very common in ICU patients and may worsen illness outcomes. This international randomized trial aims to find out if correcting this deficiency rapidly makes a meaningful difference. You may be eligible if: - You are 18 years of age or older - You are in the ICU and expected to stay for at least 48 hours - You were admitted to the ICU within the last 72 hours - Your vitamin D level is very low (12 ng/mL or less, or undetectable) You may NOT be eligible if: - You have severe gastrointestinal problems preventing you from taking oral medication - You have a do-not-resuscitate (DNR) order or are expected to die imminently - You have high blood calcium levels (hypercalcemia) - You have a recent history of kidney stones, active tuberculosis, or sarcoidosis - You are pregnant or breastfeeding - Your medical team does not think participation is appropriate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCholecalciferol

oral/enteral loading dose of 37.5 ml MCT including 540,000 IU vitamin D3 followed by 10 drops daily (4000 IU) for 90 days

DRUGPlacebo

oral/enteral loading dose of 37.5 ml MCT followed by 10 drops daily for 90 days


Locations(18)

LKH Enzenbach

Enzenbach, Austria

LKH Feldbach

Feldbach, Austria

Medical University of Graz

Graz, Austria

Klinikum am Wörthersee

Klagenfurt, Austria

LKH Hochsteiermark Standort Leoben

Leoben, Austria

Barmherzige Schwestern

Linz, Austria

Kepler Universitätsklinikum Linz

Linz, Austria

Krankenhaus Schwarzach

Schwarzach im Pongau, Austria

Barmherzige Brüder

Vienna, Austria

Kaiser Franz Josef Spital Wien

Vienna, Austria

Medical University of Vienna

Vienna, Austria

LKH Villach

Villach, Austria

Erasme Hospital

Brussels, Belgium

CHU de Charleroi

Charleroi, Belgium

CHR Citadelle

Liège, Belgium

CHU Ambroise Pare

Mons, Belgium

University Hospital Wuerzburg

Würzburg, Germany

University of Birmingham

Birmingham, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03188796


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