Effect of high-dose vitamin D on 28-day mortality in adult critically ill patients with severe vitamin D deficiency

Phase 1

• Conditions: Adult critically ill patients with severe vitamin D deficiency; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-002460-13-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-15
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

1.Age =18 years
2.Expected primary ICU stay = 48 hours
3.= 72 hours in primary ICU at screening blood sample
4.Severe vitamin D deficiency (=12 ng/ml or undetectable)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1200

Exclusion Criteria

1.Hypercalcemia at inclusion (total Ca > 2.65 mmol/l, ionized Ca > 1.35 mmol/l)
2.Study medication intake not possible (mask, ileus, residual volume high)
3.History of kidney stones (= 1 year)
4.Granulomatous disease (active tuberculosis or sarcoidosis)
5.Pregnant/nursing
6.Other reasons* (DNR= do not resuscitate, relevant psychiatric disease, prisoner)
7.Hypersensitivity to drug or excipient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test if high-dose vitamin D3 is beneficial for the clinical outcome of critically ill adult patients with severe vitamin D deficiency<br>28-day mortality<br>;Secondary Objective: 90-day mortality<br>1-year mortality<br>ICU and hospital mortality<br>Hospital and ICU length of stay<br>SOFA Score at day 5 (48 hours tolerance) and number of organ failures (> 2 SOFA points in each of the 6 categories)<br>Katz Activities of Daily Life (ADL) at day 90<br>Self - reported infections requiring antibiotics until day 90<br>Hospital and ICU readmission until day 90<br><br>Hypercalcemia on day 5 (48 hours tolerance)<br>Self-reported falls, fractures until day 90<br>New episodes of kidney stones<br>;Primary end point(s): 28-day mortality;Timepoint(s) of evaluation of this end point: 28 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 90-day mortality<br>1-year mortality<br>ICU and hospital mortality<br>Hospital and ICU length of stay<br>SOFA Score at day 5 (48 hours tolerance) and number of organ failures (> 2 SOFA points in each of the 6 categories)<br>Katz Activities of Daily Life (ADL) at day 90<br>Self - reported infections requiring antibiotics until day 90<br>Hospital and ICU readmission until day 90<br><br>Hypercalcemia on day 5 (48 hours tolerance)<br>Self-reported falls, fractures until day 90<br>New episodes of kidney stones<br>;Timepoint(s) of evaluation of this end point: up to 1 year