High-dose versus standard-dose vitamin D supplementation in older adults with COVID-19

Vitamin D supplementation has been proposed as a treatment for Coronavirus Disease 2019 (COVID-19) based on experimental data and data from small and uncontrolled observational studies. The COvid19 and VITamin d TRIAL (COVIT-TRIAL) study was conducted to test whether a single oral high dose of chole...

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Published in:PLoS medicine 2022-05, Vol.19 (5)
Main Authors: Annweiler, Cédric, Beaudenon, Mélinda, Gautier, Jennifer, Gonsard, Justine, Boucher, Sophie, Chapelet, Guillaume, Darsonval, Astrid, Fougère, Bertrand, Guérin, Olivier, Houvet, Marjorie, Ménager, Pierre, Roubaud-Baudron, Claire, Tchalla, Achille, Souberbielle, Jean-Claude, Riou, Jérémie, Parot-Schinkel, Elsa, Célarier, Thomas
Format: Article
Language:English
Subjects:
Alfacalcidol
Calcifediol
Dosage and administration
Dose-response relationship (Biochemistry)
Drug therapy, Combination
Evaluation
Management
Patient outcomes
Vitamin D
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Summary:Vitamin D supplementation has been proposed as a treatment for Coronavirus Disease 2019 (COVID-19) based on experimental data and data from small and uncontrolled observational studies. The COvid19 and VITamin d TRIAL (COVIT-TRIAL) study was conducted to test whether a single oral high dose of cholecalciferol (vitamin D3) administered within 72 hours after the diagnosis of COVID-19 improves, compared to standard-dose cholecalciferol, the 14-day overall survival among at-risk older adults infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). This multicenter, randomized, controlled, open-label, superiority trial involved collaboration of 9 medical centers in France. Patients admitted to the hospital units or living in nursing homes adjacent to the investigator centers were eligible if they were [greater than or equal to]65 years, had SARS-CoV-2 infection of less than 3 days, and at least 1 COVID-19 worsening risk factor (among age [greater than or equal to]75 years, SpO2 [less than or equal to]94%, or PaO.sub.2 /FiO.sub.2 [less than or equal to]300 mm Hg). Main noninclusion criteria were organ failure requiring ICU, SpO2 [less than or equal to]92% despite 5 L/min oxygen, life expectancy 800 IU/day during the preceding month, and contraindications to vitamin D supplements. Eligible and consenting patients were randomly allocated to either a single oral high-dose (400,000 IU) or standard-dose (50,000 IU) cholecalciferol administered under medical supervision within 72 hours after the diagnosis of COVID-19. Participants and local study staff were not masked to the allocated treatment, but the Steering Committee and the Data and Safety Monitoring Board were masked to the randomization group and outcome data during the trial. The primary outcome was 14-day overall mortality. Between April 15 and December 17, 2020, of 1,207 patients who were assessed for eligibility in the COVIT-TRIAL study, 254 met eligibility criteria and formed the intention-to-treat population. The median age was 88 (IQR, 82 to 92) years, and 148 patients (58%) were women. Overall, 8 (6%) of 127 patients allocated to high-dose cholecalciferol, and 14 (11%) of 127 patients allocated to standard-dose cholecalciferol died within 14 days (adjusted hazard ratio = 0.39 [95% confidence interval [CI], 0.16 to 0.99], P = 0.049, after controlling for randomization strata [i.e., age, oxygen requirement, hospitalization, use of antibiotics, anti-infective drugs, and/or corticosteroi
ISSN:1549-1277
1549-1676
DOI:10.1371/journal.pmed.1003999