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

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 - VITDALIZE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002460-13-AT

Enrollment

2400

Registered

2016-11-15

Start date

2017-01-03

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult critically ill patients with severe vitamin D deficiency

Interventions

Trade Name: Oleovit Pharmaceutical Form: Oral liquid INN or Proposed INN: Colecalciferol Other descriptive name: COLECALCIFEROL CONCENTRATE (OILY FORM) Concentration unit: ml millilitre(s) Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 28-day mortality ;Secondary Objective: 90-day mortality 1-year mortality ICU and hospital mortality Hospital and ICU length of stay SOFA Score at day 5 (48 hours tolerance) and number of organ failures (> 2 SOFA points in each of the 6 categories) Katz Activities of Daily Life (ADL) at day 90 Self - reported infections requiring antibiotics until day 90 Hospital and ICU readmission until day 90 Hypercalcemia on day 5 (48 hours tolerance) Self-reported falls, fractures until day 90 New episodes of kidney stones ;Primary end point(s): 28-day mortality;Timepoint(s) of evaluation of this end point: 28 days	—

Measure

Time frame

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 28-day mortality ;Secondary Objective: 90-day mortality 1-year mortality ICU and hospital mortality Hospital and ICU length of stay SOFA Score at day 5 (48 hours tolerance) and number of organ failures (> 2 SOFA points in each of the 6 categories) Katz Activities of Daily Life (ADL) at day 90 Self - reported infections requiring antibiotics until day 90 Hospital and ICU readmission until day 90 Hypercalcemia on day 5 (48 hours tolerance) Self-reported falls, fractures until day 90 New episodes of kidney stones ;Primary end point(s): 28-day mortality;Timepoint(s) of evaluation of this end point: 28 days

—

Secondary

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

Measure

Time frame

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

—

Countries

Austria, Belgium, Germany, United Kingdom

Contacts

Public ContactDivision of Endocrinology & D.

Medical University of Graz

karin.amrein@medunigraz.at004331638580798

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026