Apparent benefits were also found on 14-day mortality due to COVID-19 (7 (6%) deaths in high-dose group and 14 (11%) deaths in standard-dose group adjusted hazard ratio = 0.33, P = 0.02). The number needed to treat for one person to benefit (NNTB) was 21. 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, 0.16 to 0.99], P = 0.049, after controlling for randomization strata and baseline imbalances in important prognostic factors ). The median age was 88 (IQR, 82 to 92) years, and 148 patients (58%) were women. 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 primary outcome was 14-day overall mortality. 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. 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. Main noninclusion criteria were organ failure requiring ICU, SpO2 ≤92% despite 5 L/min oxygen, life expectancy 800 IU/day during the preceding month, and contraindications to vitamin D supplements. Patients admitted to the hospital units or living in nursing homes adjacent to the investigator centers were eligible if they were ≥65 years, had SARS-CoV-2 infection of less than 3 days, and at least 1 COVID-19 worsening risk factor (among age ≥75 years, SpO2 ≤94%, or PaO2/FiO2 ≤300 mm Hg). This multicenter, randomized, controlled, open-label, superiority trial involved collaboration of 9 medical centers in France. 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). 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. 13 Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France Chaire Santé des Ainés, University of Jean Monnet, Saint-Etienne, France.12 Service des Explorations Fonctionnelles, Hôpital Necker-Enfants Malades, AP-HP, Paris, France.11 Unité de Recherche Clinique et d'Innovation (URCI) de Gérontologie, Pôle HU Gérontologie Clinique, CHU de Limoges, France Université de Limoges, IFR GEIST, Laboratoire UR Vie-Santé (Aging and Digital health Lab) Faculté de Medicine de Limoges, Limoges, France.10 Pôle de Gérontologie Clinique, CHU Bordeaux, Bordeaux, France INSERM 1053, Univ.9 Department of Geriatric Medicine, General Hospital, Le Mans, France.8 Department of Geriatric Medicine, General Hospital, Saumur, France.7 Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, Service de Médecine Gériatrique et Thérapeutique, Nice, France Université Côte d'Azur, CNRS UMR 7284/INSERM U108, Institute for Research on Cancer and Aging Nice (IRCAN), Faculté de Médecine, Nice, France.6 Division of Geriatric Medicine, Tours University Hospital, Tours, France Education, Ethics, Health (EA 7505), Tours University, Tours, France.5 Department of Pharmacy, Angers University Hospital, Angers, France.4 Department of Geriatric Medicine and Memory Clinic, Research Centre, University Hospital, Nantes, France Inserm UMR1235, Nantes Université, Nantes, France.3 Department of ENT Head and Neck Surgery, University Hospital, Angers, France MitoLab Team Mitochondrial Medecine Research Centre, MitoVasc Intitute, UNIV Angers, CNRS UMR6015, INSERM U1083, University of Angers, Angers, France.2 Delegation for Clinical Research and Innovation, Angers University Hospital, Angers, France. ![]() 1 Department of Geriatric Medicine and Memory Clinic, Research Centre on Autonomy and Longevity, University Hospital, Angers, France UNIV Angers, UPRES EA 4638, University of Angers, Angers, France.
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