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

Study acronym: VITDALIZE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Mar 2027 → Jul 2027
See other at-risk trials from Medical University of Graz

Record History

  1. Enrollment closed, study ongoing Primary completion pushed from Mar 2027 to Jul 2027 · Completion pushed from Mar 2027 to Oct 2027 · Eligibility criteria expanded, about 10 words · 4 more Show 7 more changesShow less
    • Primary completion pushed from Mar 2027 to Jul 2027
    • Completion pushed from Mar 2027 to Oct 2027
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 18 of 18 sites
    • Collaborators: details revised at 1 of 34 entries
    • Publications: details revised at 8 of 9 entries
    • Study description expanded, about 2 words
  2. Primary completion date: Dec 2026 to Mar 2027v17
  3. Primary completion date: Dec 2024 to Dec 2026 Study sites: 16 to 18 · Completion date: Mar 2025 to Mar 2027 · Publications: 7 to 9v16 Show 3 more changesShow less
    • Study sites: 16 to 18
    • Completion date: Mar 2025 to Mar 2027
    • Publications: 7 to 9

    See this version in full on ClinicalTrials.gov ↗

  4. Site details revised at 7 of 16 sites Collaborators: 31 to 34v15 Show 1 more changeShow less
    • Collaborators: 31 to 34

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  5. Collaborators: 28 to 31v14 See this version in full on ClinicalTrials.gov ↗
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 20 to 16 Collaborators: 27 to 28v13 Show 1 more changeShow less
    • Collaborators: 27 to 28

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Dec 2022 to Dec 2024 Completion date: Feb 2023 to Mar 2025 · Collaborators: 23 to 27v12 Show 2 more changesShow less
    • Completion date: Feb 2023 to Mar 2025
    • Collaborators: 23 to 27

    See this version in full on ClinicalTrials.gov ↗

  3. Collaborators: 20 to 23v11 See this version in full on ClinicalTrials.gov ↗
  4. Collaborators: 16 to 20v10 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv9
  6. Primary completion date: Dec 2020 to Dec 2022 Study sites: 8 to 20 · Completion date: Feb 2021 to Feb 2023 · Collaborators revised (16) · 1 morev8 Show 4 more changesShow less
    • Study sites: 8 to 20
    • Completion date: Feb 2021 to Feb 2023
    • Collaborators revised (16)
    • Publications: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  7. Publications: 5 to 6v7 See this version in full on ClinicalTrials.gov ↗
  8. Collaborators: 13 to 16v6 See this version in full on ClinicalTrials.gov ↗
  9. Collaborators: 11 to 13v5 See this version in full on ClinicalTrials.gov ↗
  10. Study sites: 1 to 8 Collaborators: 7 to 11v4 Show 1 more changeShow less
    • Collaborators: 7 to 11

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  11. Collaborators: 1 to 7v3 See this version in full on ClinicalTrials.gov ↗
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Oct 2017 to Oct 10, 2017 · Eligibility criteria shortened, about 2 wordsv2 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2017 to Oct 10, 2017
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03188796
Lead Sponsor Medical University of Graz
Collaborators: Medical University of Vienna, Hospital Barmherzige Brüder St. Veit, Klinikum Klagenfurt am Wörthersee, Johannes Kepler University of Linz, Krankenhaus Barmherzige Schwestern Linz, Barmherzige Brüder Vienna, Erasme University Hospital, The Queen Elizabeth Hospital, Goethe University, Kages, KABEG Management, Centre Hospitalier Régional de la Citadelle, Centre Hospitalier Universitaire de Charleroi, Centre Hospitalier Universitaire Mons, Wuerzburg University Hospital, Royal Bolton Hospital NHS Foundation Trust, Heartlands Hospital, Royal Oldham Hospital, East Lancashire Hospitals NHS Trust, University of Plymouth, Royal Victoria Hospital, Belfast, Great Western Hospital, Mid Yorkshire Teaching NHS Trust, Musgrove Park Hospital, Scunthorpe General Hospital, Guy's and St Thomas' NHS Foundation Trust, Nottingham University Hospitals NHS Trust, Hospital Barmherzige Brüder Graz, University Hospital Schleswig-Holstein, University Hospital, Bonn, Johannes Gutenberg University Mainz, University Hospital, Essen, Klinikum rechts der Isar der TUM, Landeskrankenhaus Villach
Conditions Critical Illness, Vitamin D Deficiency, Covid19
Enrollment 2,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov