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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Graz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

15 Feb 2017 → ongoing

Decision date (initial)

2025-01-27

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-514556-32-00

EudraCT number

2016-002460-13

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To test if high-dose vitamin D3 is beneficial for the clinical outcome of
critically ill adult patients with severe vitamin D deficiency
28-day mortality

Secondary objectives 11

1. 90-day mortality
2. 1-year mortality
3. ICU and hospital mortality
4. Hospital and ICU length of stay
5. SOFA Score at day 5 (48 hours tolerance) and number of organ failures (> 2 SOFA points in each of the 6 categories)
6. Katz Activities of Daily Life (ADL) at day 90
7. Self - reported infections requiring antibiotics until day 90
8. Hospital and ICU readmission until day 90
9. Hypercalcemia on day 5 (48 hours tolerance)
10. Self-reported falls, fractures until day 90
11. New episodes of kidney stones

Conditions and MedDRA coding

Adult critically ill patients with severe vitamin D deficiency

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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)

Exclusion criteria 7

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 28-day mortality

Secondary endpoints 11

1. 90-day mortality
2. 1-year mortality
3. ICU and hospital mortality
4. Hospital and ICU length of stay
5. SOFA Score at day 5 (48 hours tolerance) and number of organ failures (> 2 SOFA points in each of the 6 categories)
6. Katz Activities of Daily Life (ADL) at day 90
7. Self - reported infections requiring antibiotics until day 90
8. Hospital and ICU readmission until day 90
9. Hypercalcemia on day 5 (48 hours tolerance)
10. Self-reported falls, fractures until day 90
11. New episodes of kidney stones

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Graz

Sponsor organisation

Medical University Of Graz

Address

Neue Stiftingtalstrasse 6

City

Graz

Postcode

8010

Country

Austria

Scientific contact point

Organisation

Medical University Of Graz

Contact name

Karin Amrein

Public contact point

Organisation

Medical University Of Graz

Contact name

Karin Amrein

Locations

2 EU/EEA countries · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 54 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications