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 randomized multicentre international clinical trial.

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, randomized, open label, clinical trial conducted throughout one year. Patients older than 18 years with moderate-severe COVID-19 disease requiring hospitalization 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 hospitalization, admission to intensive care unit (ICU) and mortality, were assessed. Results: In the randomized 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 hospitalization (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 randomized 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 authorized by the Spanish Agency for Medicines and Health products (AEMPS) and registered in European Union Drug Regulating Authorities Clinical Trials 3 (EudraCT 2020-002274-28) and in ClinicalTrials.gov (NCT04552951). https://clinicaltrials.gov/ct2/show/NCT04552951.