A single-oral bolus of 100,000 IU of cholecalciferol at hospital admission did not improve outcomes in the COVID-19 disease: the COVID-VIT-D-a randomised multicentre international clinical trial
Cannata-Andía JB, Díaz-Sottolano A, Fernández P, Palomo-Antequera C, Herrero-Puente P, Mouzo R, Carrillo-López N, Panizo S, Ibañez GH, Cusumano CA, Ballarino C, Sánchez-Polo V, Pefaur-Penna J, Maderuelo-Riesco I, Calviño-Varela J, Gómez MD, Gómez-Alonso C, Cunningham J, Naves-Díaz M, Douthat W, Fernández-Martín JL, COVID-VIT-D trial collaborators
BMC medicine · 50 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
Who paid for it
- Funding
- Independent funding
- Government
- European Commission
- University or hospital
- Universidad de Oviedo
- Government
- Agencia Española de Medicamentos y Productos Sanitarios
- University or hospital
- Instituto de Investigación Sanitaria del Principado de Asturias
- Government
- Instituto de Salud Carlos III
- Government
- European Regional Development Fund
- Authors
- At least one author declares a financial tie to industry
- Grants
- Instituto de Salud Carlos III (RD16/0009); Instituto de Salud Carlos III (RD21/0005/0019); Instituto de Salud Carlos III (RD12/0021); Instituto de Salud Carlos III (PI17/02181); Instituto de Salud Carlos III (RD21/0005); European Commission (2018-2022); European Commission (RD16/0009); Instituto de Salud Carlos III (RI-CORS2040); European Regional Development Fund (RICORS2040); European Regional Development Fund (RD16/0009); Instituto de Salud Carlos III (RD16/0009/0017); Instituto de Salud Carlos III (PI17/00715); Instituto de Salud Carlos III (PI20/00753); Instituto de Salud Carlos III (PI20/00633); European Commission (IDI/2021/000080); Instituto de Salud Carlos III (PI19/00532); European Commission (PI20/00633); European Commission (PI17/00384); Instituto de Salud Carlos III (PI17/00384)
Based on 6 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2022-02-18 · BMC Med · vol. 20 · issue 1 · p. 83
- Publisher
- BioMed Central
- Cited
- 70 citations · more than 99% of similar papers · 9.0× the field average
- Impact
- Top 10% most cited in its field
- References
- 63 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Vitamin D Research Studies · COVID-19 Clinical Research Studies · Pancreatitis Pathology and Treatment
- Keywords
- Medicine, Cholecalciferol, Vitamin D and neurology, Internal medicine, Intensive care unit, Cohort, Bolus (digestion), Clinical trial, vitamin D deficiency, Coronavirus disease 2019 (COVID-19), Cohort study, Pediatrics, Gastroenterology, Disease, Infectious disease (medical specialty)
- MeSH
- humans, cholecalciferol, vitamin d, treatment outcome, hospitalization, double-blind method, hospitals, covid-19, sars-cov-2
22 authors
From ES, AR, GT, CL, GB
- Jorge Benito Cannata-Andía · correspondingUniversidad de Oviedo; Hospital Universitario Central de Asturias; Instituto de Investigación Sanitaria del Principado de Asturias
- Augusto Díaz-SottolanoInstituto de Investigación Sanitaria del Principado de Asturias
- Pehuén FernándezServicio Diabetología Hospital Córdoba; Instituto de Investigación Médica Mercedes y Martín Ferreyra; Hospital Privado; Instituto Universitario de Ciencias Biomédicas de Córdoba
- Carmen Palomo-AntequeraUniversidad de Oviedo; Hospital Universitario Central de Asturias; Instituto de Investigación Sanitaria del Principado de Asturias
- Pablo HerreroUniversidad de Oviedo; Hospital Universitario Central de Asturias; Instituto de Investigación Sanitaria del Principado de Asturias
- Ricardo MouzoHospital El Bierzo
Abstract
Background
Vitamin D status has been implicated in COVID-19 disease. The objective of the COVID-VIT-D trial was to investigate if an oral bolus of cholecalciferol (100,000 IU) administered at hospital admission influences the outcomes of moderate-severe COVID-19 disease. In the same cohort, the association between baseline serum calcidiol levels with the same outcomes was also analysed.
Methods
The COVID-VIT-D is a multicentre, international, randomised, open label, clinical trial conducted throughout 1 year. Patients older than 18 years with moderate-severe COVID-19 disease requiring hospitalisation were included. At admission, patients were randomised 1:1 to receive a single oral bolus of cholecalciferol (n=274) or nothing (n=269). Patients were followed from admission to discharge or death. Length of hospitalisation, admission to intensive care unit (ICU) and mortality were assessed.
Results
In the randomised trial, comorbidities, biomarkers, symptoms and drugs used did not differ between groups. Median serum calcidiol in the cholecalciferol and control groups were 17.0 vs. 16.1 ng/mL at admission and 29.0 vs. 16.4 ng/mL at discharge, respectively. The median length of hospitalisation (10.0 [95%CI 9.0-10.5] vs. 9.5 [95%CI 9.0-10.5] days), admission to ICU (17.2% [95%CI 13.0-22.3] vs. 16.4% [95%CI 12.3-21.4]) and death rate (8.0% [95%CI 5.2-12.1] vs. 5.6% [95%CI 3.3-9.2]) did not differ between the cholecalciferol and control group. In the cohort analyses, the highest serum calcidiol category at admission (>25ng/mL) was associated with lower percentage of pulmonary involvement and better outcomes.
Conclusions
The randomised clinical trial showed the administration of an oral bolus of 100,000 IU of cholecalciferol at hospital admission did not improve the outcomes of the COVID-19 disease. A cohort analysis showed that serum calcidiol at hospital admission was associated with outcomes.
Trial registration
COVID-VIT-D trial was authorised by the Spanish Agency for Medicines and Health products (AEMPS) and registered in European Union Drug Regulating Authorities Clinical Trials (EudraCT 2020-002274-28) and in ClinicalTrials.gov ( NCT04552951 ).
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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