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
Jorge B Cannata-Andía, Augusto Díaz-Sottolano, Pehuén Fernández, Carmen Palomo-Antequera, Pablo Herrero-Puente, Ricardo Mouzo, Natalia Carrillo-López, Sara Panizo, Guillermo H Ibañez, Carlos A Cusumano, Carolina Ballarino, Vicente Sánchez-Polo, Jacqueline Pefaur-Penna, Irene Maderuelo-Riesco, Jesús Calviño-Varela, Mónica D Gómez, Carlos Gómez-Alonso, John Cunningham, Manuel Naves-Díaz, Walter Douthat, José L Fernández-Martín
BMC Medicine, doi:10.1186/s12916-022-02290-8
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.
Abbreviations AEMPs: Spanish Agency for Medicines and Health Products; BMI: Body mass index; CAT : Computed axial tomography; CRP: C-reactive protein; HUCA : Hospital Universitario Central de Asturias; ICU: Intensive care unit; IL-6: Interleukin 6; PCR: Polymerase chain reaction; SARS-CoV-2: Severe Acute Respiratory Syndrome CoronaVirus 2.
Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1186/ s12916-022-02290-8. S1 . Variables collected in the COVID-VIT-D trial. T. Table S2 . Symptoms at discharge. Table S3 . Biochemical parameters at discharge. Table S4 . Demographic, comorbidities, and serum calcidiol categories at hospital admission. Table S5 . Relevant biochemical parameters and serum calcidiol categories at hospital admission. Table S6 . Relevant biochemical parameters and serum calcidiol categories at hospital admission in age-matched patients. Table S7 . Pulmonary involvement at admission and outcomes according to serum calcidiol categories. Table S8 . Types and number of drugs received during the hospitalization and serum calcidiol categories at hospital admission. Table S9 . Demographic, comorbidities, and serum calcidiol categories at admission in agematched patients. Table S10 . Types and number of drugs received during the hospitalization and serum calcidiol categories at hospital admission in age-matched patients. Table S11 . Relevant biochemical parameters and serum calcidiol..
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DOI record:
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"abstract": "<jats:title>Abstract</jats:title><jats:sec>\n <jats:title>Background</jats:title>\n <jats:p>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.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>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 (<jats:italic>n</jats:italic>=274) or nothing (<jats:italic>n</jats:italic>=269). Patients were followed from admission to discharge or death. Length of hospitalisation, admission to intensive care unit (ICU) and mortality were assessed.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>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<jats:italic>.</jats:italic> 16.1 ng/mL at admission and 29.0 vs<jats:italic>.</jats:italic> 16.4 ng/mL at discharge, respectively. The median length of hospitalisation (10.0 [95%CI 9.0–10.5] vs<jats:italic>.</jats:italic> 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<jats:italic>.</jats:italic> 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.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Conclusions</jats:title>\n <jats:p>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.</jats:p>\n </jats:sec><jats:sec>\n <jats:title>Trial registration</jats:title>\n <jats:p>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 (<jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://clinicaltrials.gov/ct2/show/NCT04552951\">NCT04552951</jats:ext-link>).</jats:p>\n </jats:sec>",
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