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 RCT

Phase 3

Recruiting

• Conditions: E55.9; Vitamin D deficiency, unspecified

• Registration Number: DRKS00016940
• Lead Sponsor: niversitätsklinikum Würzburg (Sponsor in Deutschland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

=18 years
- Anticipated ICU stay = 48 hours
- Admission to ICU = 72 hours before screening
- Severe vitamin D deficiency (=12 ng/ml or not determined)

Exclusion Criteria

- Severe gastrointestinal dysfunction (> 400 ml residual volume)/unable to take study medication
- DNR order/imminent death
- hypercalcemia
- known nephrolithiasis, active tuberculosis or sarcoidosis (within the last 12 months)
- pregnancy/lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day mortality

Secondary Outcome Measures

Name	Time	Method
-90-day mortality<br>-1-year mortality<br>-ICU and hospital mortality rates<br>-Duration of stay in Hospital and intensive care unit <br>-SOFA score on day 5 (48 hours tolerance) and number of organ failures (> 2 SOFA points in each of the 6 categories)<br>-Cat activities of daily life (ADL) on day 90<br>Self-reported infections that require antibiotics by day 90<br>-hospital and intensive care unit up to day 90<br>-Discharge type