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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 Orcid Logo, Hayley Holt, Matthew Greenig, Mohammad Talaei Orcid Logo, Natalia Perdek, Paul Pfeffer Orcid Logo, Giulia Vivaldi Orcid Logo, Sheena Maltby, Jane Symons Orcid Logo, Nicola L Barlow, Alexa Normandale, Rajvinder Garcha, Alex G Richter Orcid Logo, Sian E Faustini Orcid Logo, Chris Orton Orcid Logo, David Ford Orcid Logo, Ronan Lyons Orcid Logo, Gwyneth Davies Orcid Logo, Frank Kee Orcid Logo, Christopher J Griffiths, John Norrie, Aziz Sheikh Orcid Logo, Seif O Shaheen Orcid Logo, Clare Relton, Adrian R Martineau Orcid Logo

BMJ, Start page: e071230

Swansea University Authors: Chris Orton Orcid Logo, David Ford Orcid Logo, Ronan Lyons Orcid Logo, Gwyneth Davies Orcid Logo

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DOI (Published version): 10.1136/bmj-2022-071230

Abstract

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 contro...

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Published in: BMJ
ISSN: 1756-1833
Published: BMJ 2022
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URI: https://cronfa.swan.ac.uk/Record/cronfa61819
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Abstract: 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.
Item Description: Clinical Trial
College: Faculty of Medicine, Health and Life Sciences
Funders: This study was supported by Barts Charity (refs MGU0459 and MGU0466), Pharma Nord, the Fischer Family Foundation, DSM Nutritional Products, the Exilarch’s Foundation, the Karl R Pfleger Foundation, the AIM Foundation, Synergy Biologics, Cytoplan, the UK National Institute for Health and Care Research Clinical Research Network (refs 52255 and 52257), the HDR UK BREATHE Hub, the UK Research and Innovation Industrial Strategy Challenge Fund (ref MC_PC_19004), Thornton & Ross, Warburtons, Hyphens Pharma, and a personal donation from Matthew Isaacs (a philanthropist without financial interests constituting a potential conflict). MT was supported by a grant from the Rosetrees Trust and The Bloom Foundation (ref M771) until May 2021 and has been supported by the Barts Charity since then (ref MGU0570).
Start Page: e071230

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