Evidence map›Paper›PMID 31722941›Full record

ArticleBMJ open2019

Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency: a study protocol of a multicentre, placebo-controlled double-blind phase III RCT (the VITDALIZE study).

Karin Amrein, Dhruv Parekh, Sabine Westphal, Jean-Charles Preiser, Andrea Berghold, Regina Riedl, Philipp Eller, Peter Schellongowski, David Thickett, Patrick Meybohm and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03188796 (The VITDALIZE Study), which is not on this map. Cited by 34 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 5 pooled it
11.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03188796 phase3recruitingnot on this map

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 Randomized Controlled Trial (RCT)

TypeinterventionalSponsorMedical University of GrazRan2017 to 2027Enrolled2,400ConditionsCritical Illness, Vitamin D Deficiency, Covid19ArmsCholecalciferol, Placebo
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 5 syntheses or guidelines pooled it, 120 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. The Role of Vitamin D and Vitamin D Receptor in Sepsis.Current issues in molecular biology · 2025
    Review
  12. Article
  13. Article
  14. Observational
  15. Article
  16. Update on vitamin D role in severe infections and sepsis.Journal of anesthesia, analgesia and critical care · 2024
    Review
  17. Observational
  18. [Vitamin C and D supplementation in critically ill patients].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2023
    Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 4 countries.

Karin AmreinDepartment of Internal Medicine, Medical University of Graz, Graz, Austria.
Dhruv ParekhBirmingham Acute Care Research Group, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.ORCID 0000-0002-1508-8362
Sabine WestphalDepartment of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.
Jean-Charles PreiserIntensive Care Medicine, Erasme University Hospital, Brussels, Belgium.
Andrea BergholdInstitute for Medical Informatics, Statstics, and Documentation, Medical University of Graz, Graz, Austria.
Regina RiedlInstitute for Medical Informatics, Statstics, and Documentation, Medical University of Graz, Graz, Austria.
Philipp EllerIntensive Care Unit, Department of Internal Medicine, University Hospital of Graz, Graz, Austria.ORCID 0000-0001-5537-3646
Peter SchellongowskiUniversity Hospital of Internal Medicine I, Medical University Wien, Wien, Austria.
David ThickettBirmingham Acute Care Research Group, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Patrick MeybohmDepartment of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University, Frankfurt, Germany patrick.meybohm@kgu.de.
VITDALIZE Collaboration Group
Medical University of Graz · ATGoethe University Frankfurt · DEUniversity Hospitals Birmingham NHS Foundation Trust · GBErasmus Hospital · BEGraz University Hospital · AT

Funding

Department of HealthMedical Research Council G1100196Medical Research Council MR/J011266/1Medical Research Council MR/L002736/1Medical Research Council MR/S002782/1
6 · The paper itself

Abstract

introductionObservational studies have demonstrated an association between vitamin D deficiency and increased risk of morbidity and mortality in critically ill patients. Cohort studies and pilot trials have suggested promising beneficial effects of vitamin D replacement in the critical ill, at least in patients with severe vitamin D deficiency. As vitamin D is a simple, low-cost and safe intervention, it has potential to improve survival in critically ill patients. METHODS AND ANALYSIS: In this randomised, placebo-controlled, double-blind, multicentre, international trial, 2400 adult patients with severe vitamin D deficiency (25-hydroxyvitamin D≤12 ng/mL) will be randomised in a 1:1 ratio by www.randomizer.at to receive a loading dose of 540 000 IU cholecalciferol within 72 hours after intensive care unit (ICU) admission, followed by 4000 IU daily for 90 days or placebo. Hypercalcaemia may occur as a side effect, but is monitored by regular checks of the calcium level. The primary outcome is all-cause mortality at 28 days after randomisation. Secondary outcomes are: ICU, hospital, 90-day and 1-year mortality; hospital and ICU length of stay, change in organ dysfunction on day 5 as measured by Sequential Organ Function Assessment (SOFA) score, number of organ failures; hospital and ICU readmission until day 90; discharge destination, self-reported infections requiring antibiotics until day 90 and health-related quality of life. Recruitment status is ongoing. ETHICS AND DISSEMINATION: National ethical approval was obtained by the Ethics Committee of the University of Graz for Austria, Erasme University Brussels (Belgium) and University Hospital Frankfurt (Germany), and will further be gained according to individual national processes. On completion, results will be published in a peer-reviewed scientific journal. The study findings will be presented at national and international meetings with abstracts online.

trial registrationNCT03188796, EudraCT-No: 2016-002460-13.

Indexed as

AdultCholecalciferolClinical Trials, Phase III as TopicCritical IllnessDouble-Blind MethodDrug Administration ScheduleFemaleHumansIntensive Care UnitsMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicVitamin D DeficiencyVitaminsCholecalciferolVitaminscritically ill patientsintensive care unitsevere vitamin D deficiencyvitamin Dvitamin D supplementation

Identifiers

PMID31722941
PMCPMC6858186
OpenAlexW2983252669

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.