High-dose Versus Standard-dose Vitamin D Supplementation In Older ...

Citation: Annweiler C, Beaudenon M, Gautier J, Gonsard J, Boucher S, Chapelet G, et al. (2022) High-dose versus standard-dose vitamin D supplementation in older adults with COVID-19 (COVIT-TRIAL): A multicenter, open-label, randomized controlled superiority trial. PLoS Med 19(5): e1003999. https://doi.org/10.1371/journal.pmed.1003999

Academic Editor: Suzanne C. Cannegieter, Leiden University Medical Center, NETHERLANDS

Received: July 12, 2021; Accepted: April 26, 2022; Published: May 31, 2022

Copyright: © 2022 Annweiler et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: Patient level data are freely available at [email protected] to qualifying researchers registered with an appropriate institution and who submit a proposal with a valuable research question. There is no personal identification risk within this anonymized raw data, which is available after notification and authorization of the competent authorities. The steering committee will need to be satisfied that any proposed publication is of high quality, honours the commitments made to the study participants in the consent documentation and ethical approvals, and is compliant with relevant legal and regulatory requirements (eg, relating to data protection and privacy). The steering committee will have the right to review and comment on any draft manuscripts before publication.

Funding: The study was financially supported by the patronage department of Angers University Hospital (March 24, 2020) (CA). Mylan supplied the vitamin D3 supplement used in the study (CA). The sponsors had no role in the design and conduct of the study, in the collection, management, analysis, and interpretation of the data, or in the preparation, review, or approval of the manuscript.

Competing interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: CA occasionally serves as a consultant for Mylan company. The Mylan company supplied the vitamin D3 supplement used in the study. All other authors declare they do not have any financial and personal conflicts of interest with this manuscript (MB, JGa, JGo, SB, GC, AD, BF, OG, MH, PM, CRB, AT, JCS, JR, EPS, TC).

Abbreviations:: ACE2, angiotensin converting enzyme 2; ANSM, French National Agency for Medicines and Health Products Safety; CI, confidence interval; CONSORT, Consolidated Standards of Reporting Trials; COVID-19, Coronavirus Disease 2019; COVIT-TRIAL, COvid19 and VITamin d TRIAL; CT, computed tomography; ICU, intensive care unit; IQR, interquartile range; NNTB, number needed to treat for one person to benefit; NNTH, number needed to treat for one person to harm; PaO2/FiO2, partial pressure of oxygen in arterial blood/fraction of inspired oxygen ratio; RCT, randomized controlled trial; RT-PCR, reverse transcription polymerase chain reaction; SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus 2; SD, standard deviation; 25(OH)D, 25-hydroxyvitamin D; SpO2, peripheral capillary oxygen saturation