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). (7th September 2022)

• Record Type: Journal Article
• Authors: Jolliffe, David A; Holt, Hayley; Greenig, Matthew; Talaei, Mohammad; Perdek, Natalia; Pfeffer, Paul; Vivaldi, Giulia; Maltby, Sheena; Symons, Jane; Barlow, Nicola L; Normandale, Alexa; Garcha, Rajvinder; Richter, Alex G; Faustini, Sian E; Orton, Christopher; Ford, David; Lyons, Ronan A; Davies, Gwyneth A; Kee, Frank; Griffiths, Christopher J; Norrie, John; Sheikh, Aziz; Shaheen, Seif O; Relton, Clare; Martineau, Adrian R
• Is Part Of: BMJ. Volume 378(2022)
• Publication Date: 2022-09-07
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Periodicals; 610
• DOI: 10.1136/bmj-2022-071230
• Languages: English
• ISSNs: 0007-1447

Abstract

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. Trial registration: ClinicalTrials.gov NCT04579640 .