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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).

Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, UK. Asthma UK Centre for Applied Research, Queen Mary University of London, London, UK. Jane Symons Media, London, UK. Clinical Biochemistry Department, Black Country Pathology Services, City Hospital, Birmingham, UK. Institute of Immunology and Immunotherapy, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. Population Data Science, Swansea University Medical School, Swansea, UK. Health Data Research UK BREATHE Hub, Swansea University, Swansea, UK. Asthma UK Centre for Applied Research, University of Edinburgh, Edinburgh, UK. Centre for Public Health (NI), Queen's University Belfast, Belfast, UK. Health Data Research UK BREATHE Hub, Queen Mary University of London, London, UK. Usher Institute, University of Edinburgh, Edinburgh, UK. Health Data Research UK BREATHE Hub, University of Edinburgh, Edinburgh, UK. Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, UK a.martineau@qmul.ac.uk.

BMJ (Clinical research ed.). 2022;:e071230
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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. TRIAL REGISTRATION ClinicalTrials.gov NCT04579640.

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