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All Studies   Meta Analysis    Recent:   

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 preprint), CORONAVIT, NCT04579640
Mar 2022  
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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% Vitamin D  CORONAVIT  Prophylaxis  RCT 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) c19early.org Jolliffe et al., BMJ, March 2022 Favors vitamin D Favors control
Vitamin D for COVID-19
8th treatment shown to reduce risk in October 2020
 
*, now known with p < 0.00000000001 from 120 studies, recognized in 9 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
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 see1,2.
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.
3 present an RCT showing conflicting results, 78% lower cases with vitamin D prophylaxis. In comparison,3 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 see4.
This is the 12th of 29 COVID-19 RCTs for vitamin D, which collectively show efficacy with p=0.000005.
This is the 74th of 120 COVID-19 controlled studies for vitamin D, which collectively show efficacy with p<0.0000000001 (1 in 268 sextillion).
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, 25 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.
This PaperVitamin DAll
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)
David A Jolliffe, Hayley Holt, Matthew Greenig, Mohammad Talaei, Natalia Perdek, Paul Pfeffer, Giulia Vivaldi, Sheena Maltby, Jane Symons, Nicola L Barlow, Alexa Normandale, Rajvinder Garcha, Alex G Richter, Sian E Faustini, Christopher Orton, David Ford, Ronan A Lyons, Gwyneth A Davies, Frank Kee, Christopher J Griffiths, John Norrie, Aziz Sheikh, Seif O Shaheen, Clare Relton, Adrian R Martineau
BMJ, doi:10.1136/bmj-2022-071230
Objective To determine the effect of population level implementation of a test-and-treat approach to correction of suboptimal vitamin D status (25-hydroxyvitamin D (25(OH)D) <75 nmol/L) on risk of all cause acute respiratory tract infection and covid 19. Design Phase 3 open label randomised controlled trial. setting United Kingdom. ParticiPants 6200 people aged ≥16 years who were not taking vitamin D supplements at baseline. interventiOns Offer of a postal finger prick test of blood 25(OH)D concentration with provision of a six month supply of lower dose vitamin D (800 IU/day, n=1550) or higher dose vitamin D (3200 IU/day, n=1550) to those with blood 25(OH)D concentration <75 nmol/L, compared with no offer of testing or supplementation (n=3100). Follow-up was for six months. Main OutcOMe Measures The primary outcome was the proportion of participants with at least one swab test or doctor confirmed acute respiratory tract infection of any cause. A secondary outcome was the proportion of participants with swab test confirmed covid-19. Logistic regression was used to calculate odds ratios and associated 95% confidence intervals. The primary analysis was conducted by intention to treat. results Of 3100 participants offered a vitamin D test, 2958 (95.4%) accepted and 2674 (86.3%) had 25(OH) D concentrations <75 nmol/L and received vitamin D supplements (n=1328 lower dose, n=1346 higher dose). Compared with 136/2949 (4.6%) participants in the no offer group, at least one acute respiratory tract infection of any cause occurred in 87/1515 (5.7%) in the lower dose group (odds ratio 1.26, 95% confidence interval 0.96 to 1.66) and 76/1515 (5.0%) in the higher dose group (1.09, 0.82 to 1.46). Compared with 78/2949 (2.6%) participants in the no offer group, 55/1515 (3.6%) developed covid-19 in the lower dose group (1.39, 0.98 to 1.97) and 45/1515 (3.0%) in the higher dose group (1.13, 0.78 to 1.63). cOnclusiOns Among people aged 16 years and older with a high baseline prevalence of suboptimal vitamin D status, implementation of a population level test-and-treat approach to vitamin D supplementation was not associated with a reduction in risk of all cause acute respiratory tract infection or covid-19. trial registratiOn ClinicalTrials.gov NCT04579640.
Contributors: ARM, DAJ, and CR designed the study, with input from PP, JS, DF, RAL, GAD, FK, CJG, JN, AS, SEF, AGR, and SOS. DAJ, HH, NP, SM, MT, and ARM managed the trial. AN, NLB, and RG performed the laboratory assays. DAJ, MG, MT, GV, and CO managed and analysed the data. DAJ and ARM contributed equally and are the guarantors. All the authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol. ARM wrote the first draft of the paper. All authors contributed to the interpretation of the results, review and approval of the manuscript, and the decision to submit it for publication. There were no agreements concerning confidentiality of the data between the sponsor and the authors or the institutions named in the credit lines. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. Funding:
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{ 'indexed': {'date-parts': [[2022, 9, 12]], 'date-time': '2022-09-12T20:27:26Z', 'timestamp': 1663014446868}, 'reference-count': 48, 'publisher': 'BMJ', 'license': [ { 'start': { 'date-parts': [[2022, 9, 7]], 'date-time': '2022-09-07T00:00:00Z', 'timestamp': 1662508800000}, 'content-version': 'unspecified', 'delay-in-days': 0, 'URL': 'http://creativecommons.org/licenses/by-nc/4.0/'}], 'funder': [{'DOI': '10.13039/100015652', 'name': 'Barts Charity', 'doi-asserted-by': 'publisher'}], 'content-domain': {'domain': ['bmj.com'], 'crossmark-restriction': True}, 'abstract': '<jats:title>Abstract</jats:title>\n' ' <jats:sec>\n' ' <jats:title>Objective</jats:title>\n' ' <jats:p>To determine the effect of population level implementation of a ' 'test-and-treat approach to correction of suboptimal vitamin D status (25-hydroxyvitamin D ' '(25(OH)D) &lt;75 nmol/L) on risk of all cause acute respiratory tract infection and covid ' '19.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Design</jats:title>\n' ' <jats:p>Phase 3 open label randomised controlled trial.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Setting</jats:title>\n' ' <jats:p>United Kingdom.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Participants</jats:title>\n' ' <jats:p>6200 people aged ≥16 years who were not taking vitamin D supplements at ' 'baseline.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Interventions</jats:title>\n' ' <jats:p>Offer of a postal finger prick test of blood 25(OH)D concentration with ' 'provision of a six month supply of lower dose vitamin D (800 IU/day, n=1550) or higher dose ' 'vitamin D (3200 IU/day, n=1550) to those with blood 25(OH)D concentration &lt;75 nmol/L, ' 'compared with no offer of testing or supplementation (n=3100). Follow-up was for six ' 'months.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Main outcome measures</jats:title>\n' ' <jats:p>The primary outcome was the proportion of participants with at least one ' 'swab test or doctor confirmed acute respiratory tract infection of any cause. A secondary ' 'outcome was the proportion of participants with swab test confirmed covid-19. Logistic ' 'regression was used to calculate odds ratios and associated 95% confidence intervals. The ' 'primary analysis was conducted by intention to treat.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>Of 3100 participants offered a vitamin D test, 2958 (95.4%) accepted and ' '2674 (86.3%) had 25(OH)D concentrations &lt;75 nmol/L and received vitamin D supplements ' '(n=1328 lower dose, n=1346 higher dose). Compared with 136/2949 (4.6%) participants in the no ' 'offer group, at least one acute respiratory tract infection of any cause occurred in 87/1515 ' '(5.7%) in the lower dose group (odds ratio 1.26, 95% confidence interval 0.96 to 1.66) and ' '76/1515 (5.0%) in the higher dose group (1.09, 0.82 to 1.46). Compared with 78/2949 (2.6%) ' 'participants in the no offer group, 55/1515 (3.6%) developed covid-19 in the lower dose group ' '(1.39, 0.98 to 1.97) and 45/1515 (3.0%) in the higher dose group (1.13, 0.78 to ' '1.63).</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>Among people aged 16 years and older with a high baseline prevalence of ' 'suboptimal vitamin D status, implementation of a population level test-and-treat approach to ' 'vitamin D supplementation was not associated with a reduction in risk of all cause acute ' 'respiratory tract infection or covid-19.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Trial registration</jats:title>\n' ' <jats:p>\n' ' ClinicalTrials.gov\n' ' <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ' 'xlink:href="NCT04579640" ext-link-type="clintrialgov">NCT04579640</jats:ext-link>\n' ' .\n' ' </jats:p>\n' ' </jats:sec>', 'DOI': '10.1136/bmj-2022-071230', 'type': 'journal-article', 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