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0 0.5 1 1.5 2+ Ventilation -95% Improvement Relative Risk Ventilation (b) -95% Hospitalization -41% Hospitalization (b) -17% Case -9% Case (b) -25% Case (c) -12% Case (d) -37% c19early.org/d Jolliffe et al. NCT04579640 CORONAVIT Vitamin D RCT Prophylaxis Is prophylaxis with vitamin D beneficial for COVID-19? RCT 4,464 patients in the United Kingdom (December 2020 - June 2021) Higher hospitalization with vitamin D (not stat. sig., p=0.16) Jolliffe et al., BMJ, doi:10.1136/bmj-2022-071230 Favors vitamin D Favors control
Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT)
Jolliffe et al., BMJ, doi:10.1136/bmj-2022-071230 (date from earlier preprint), CORONAVIT, NCT04579640 (history)
Jolliffe et al., Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract.., BMJ, doi:10.1136/bmj-2022-071230 (date from earlier preprint), CORONAVIT, NCT04579640
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RCT 5,979 low risk patients (0 COVID-19 deaths) in the UK, showing no significant differences with vitamin D prophylaxis. CORONAVIT. NCT04579640 (history). For more discussion see [reddit.com, twitter.com].
51% of confirmed COVID-19 cases were hospitalized in the control arm which is 7 times the median rate in other studies reporting both cases and hospitalization as of Sep 2022 (7.2%), suggesting possible issues with the data or major differences between the study population and the general population.
Authors do not provide exact start/end dates (month only) or specify when infections occurred, however based on cases in the UK, most infections may have been closer to the start of the trial when vitamin D levels may still have been relatively low. Reportedly, authors do not plan to analyze this issue, and have declined to allow one of the funders access to the data.
[Villasis-Keever] present an RCT showing conflicting results, 78% lower cases with vitamin D prophylaxis. In comparison, [Villasis-Keever] used a higher dose, the participants had much higher exposure to SARS-CoV-2 patients, and the study was prior to vaccination. In this study, 89% of participants had received a vaccine dose by the end of the study period, and the period overlapped with increasing solar UVB.
For other limitations and concerns see [Nicoll].
risk of mechanical ventilation, 94.7% higher, RR 1.95, p = 1.00, treatment 1 of 1,515 (0.1%), control 1 of 2,949 (0.0%), 3200IU/day.
risk of mechanical ventilation, 94.7% higher, RR 1.95, p = 1.00, treatment 1 of 1,515 (0.1%), control 1 of 2,949 (0.0%), 800IU/day.
risk of hospitalization, 41.1% higher, RR 1.41, p = 0.16, treatment 29 of 1,515 (1.9%), control 40 of 2,949 (1.4%), 3200IU/day.
risk of hospitalization, 16.8% higher, RR 1.17, p = 0.60, treatment 24 of 1,515 (1.6%), control 40 of 2,949 (1.4%), 800IU/day.
risk of case, 8.8% higher, RR 1.09, p = 0.55, treatment 76 of 1,515 (5.0%), control 136 of 2,949 (4.6%), 3200IU/day.
risk of case, 24.5% higher, RR 1.25, p = 0.11, treatment 87 of 1,515 (5.7%), control 136 of 2,949 (4.6%), 800IU/day.
risk of case, 12.3% higher, RR 1.12, p = 0.56, treatment 45 of 1,515 (3.0%), control 78 of 2,949 (2.6%), confirmed, 3200IU/day.
risk of case, 37.3% higher, RR 1.37, p = 0.08, treatment 55 of 1,515 (3.6%), control 78 of 2,949 (2.6%), confirmed, 800IU/day.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Jolliffe et al., 23 Mar 2022, Randomized Controlled Trial, United Kingdom, peer-reviewed, median age 60.2, 24 authors, study period December 2020 - June 2021, dosage 3,200IU daily, daily, trial NCT04579640 (history) (CORONAVIT).
Contact: d.a.jolliffe@qmul.ac.uk, a.martineau@qmul.ac.uk.
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This PaperVitamin DAll
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2022.03.22.22271707; this version posted March 23, 2022. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . Vitamin D Supplements for Prevention of Covid-19 or other Acute Respiratory Infections: a Phase 3 Randomized Controlled Trial (CORONAVIT) David A. Jolliffe, PhD1*† Hayley Holt, MSc1,2 Matthew Greenig, MSc1 Mohammad Talaei, PhD1 Natalia Perdek, BSc1 Paul Pfeffer, PhD1 Sheena Maltby, HDASP1 Jane Symons3 Nicola L. Barlow, FRCPath4 Alexa Normandale, MSc4 Rajvinder Garcha4 Alex G. Richter, MD5 Sian E. Faustini, PhD5 Christopher Orton, MSc6,7 David Ford, FRSA6,7 Ronan A. Lyons, MD6,7 Gwyneth A. Davies, MD2,6,7 Frank Kee, MD8 Christopher J. Griffiths, DPhil1,2,9 John Norrie, MSc10,11 Aziz Sheikh, MD2,10,11 Seif O. Shaheen, PhD1 Clare Relton, PhD1 Adrian R. Martineau, PhD1,2*† 1 NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2022.03.22.22271707; this version posted March 23, 2022. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 1 Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, U.K. 2 Asthma UK Centre for Applied Research, University of Edinburgh, Edinburgh, U.K. 3 Jane Symons Media, London, U.K. 4 Clinical Biochemistry Department, Black Country Pathology Services, City Hospital, Birmingham, U.K. 5 Institute of Immunology and Immunotherapy, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK 6 Population Data Science, Swansea University Medical School, Singleton Park, Swansea, U.K. 7 Health Data Research UK BREATHE Hub, Swansea University, Swansea, U.K. 8 Centre for Public Health (NI), Queen’s University Belfast, Belfast, U.K. 9 Health Data Research UK BREATHE Hub, Queen Mary University of London, London, U.K. 10 Usher Institute, University of Edinburgh, Edinburgh, U.K. 11 Health Data Research UK BREATHE Hub, University of Edinburgh, Edinburgh, U.K. *Contributed equally † To whom correspondence should be addressed at Barts and The London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark St, London E1 2AT, U.K. Email: d.a.jolliffe@qmul.ac.uk or a.martineau@qmul.ac.uk 2 medRxiv preprint doi: https://doi.org/10.1101/2022.03.22.22271707; this version posted March 23, 2022. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . ABSTRACT BACKGROUND: Vitamin D metabolites support innate immune responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and other respiratory pathogens. Randomized controlled trials of vitamin D to prevent coronavirus disease 2019 (Covid-19) have not yet reported. METHODS: We randomly assigned 6200 U.K. adults to receive an offer of a postal finger-prick 25-hydroxyvitamin D (25[OH]D) test with provision of a 6-month supply..
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