Vitamin D Supplements for Prevention of COVID-19 or other Acute Respiratory Infections: a Phase 3 Randomised Controlled Trial (CORONAVIT)
Vitamin D Supplements for Prevention of COVID-19 or other Acute Respiratory Infections: a Phase 3 Randomised Controlled Trial (CORONAVIT)
ABSTRACT OBJECTIVESTo determine whether population-level implementation of a test-and- treat approach to correction of sub-optimal vitamin D status (25-hydroxyvitamin D [25(OH)D] <75 nmol/L) influences risk of all-cause acute respiratory infection (ARI) or coronavirus disease 2019 (COVID-19). DESIGNPhase 3 open-label randomised controlled trial (CORONAVIT) utilising trials-within-cohorts (TwiCs) methodology. SETTINGUnited Kingdom. PARTICIPANTS6200 adults aged 16 years or older, who were not already taking vitamin D supplements at baseline. INTERVENTIONSOffer of a postal finger-prick test of blood 25(OH)D concentration with provision of a 6-month supply of higher-dose vitamin D (3200 IU/day, n=1550) or lower-dose vitamin D (800 IU/day, n=1550) to those with blood 25(OH)D concentration <75 nmol/L, vs. no offer of testing or supplementation (n=3100). Follow-up was from 17th December 2020 to 16th June 2021. MAIN OUTCOME MEASURESThe primary outcome was the proportion of participants experiencing at least one doctor- or swab test-confirmed ARI of any cause. Secondary outcomes included the proportion of participants developing swab test-confirmed COVID-19. Logistic regression was used to calculate odds ratios and associated 95% confidence intervals. RESULTSOf 3100 participants offered 25(OH)D testing, 2958 (95.4%) accepted, and 2690 (86.8%) had 25(OH)D <75 nmol/L and were sent vitamin D supplements (1356 higher-dose, 1334 lower-dose). 76 (5.0%) vs. 87 (5.7%) vs. 136 (4.6%) participants in higher-dose vs. lower-dose vs. no offer groups experienced at least one ARI of any cause (odds ratio [OR] for higher-dose vs. no offer 1.09, 95% CI 0.82-1.46; lower-dose vs. no offer 1.26, 0.96-1.66). 45 (3.0%) vs. 55 (3.6%) vs. 78 (2.6%) participants in higher-dose vs. lower-dose vs. no offer groups developed COVID-19 (OR for higher-dose vs. no offer 1.13, 0.78-1.63; lower-dose vs. no offer 1.39, 0.98-1.97). CONCLUSIONSAmong adults with a high baseline prevalence of sub-optimal vitamin D status, implementation of a population-level test-and-treat approach to vitamin D replacement did not reduce risk of all-cause ARI or COVID-19. TRIAL REGISTRATIONClinicalTrials.gov no. NCT04579640 SUMMARY BOXWhat is already known on this topic?Vitamin D metabolites support innate immune responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and other respiratory pathogens. Sub-optimal vitamin D status (25-hydroxyvitamin D <75 nmol/L) associates with increased susceptibility to all-cause acute respiratory infections (ARI) and coronavirus disease 2019 (COVID-19). Phase 3 randomised controlled trials of vitamin D to prevent COVID-19 have not yet reported.What this study addsThis phase 3 randomised controlled trial, including 6200 participants, shows that implementation of a population-level test-and-treat approach to oral vitamin D replacement at a dose of 800 IU or 3200 IU per day did not reduce risk of all-cause ARI or COVID-19 among adults with a high baseline prevalence of sub-optimal vitamin D status.
Griffiths Christopher J.、Martineau Adrian R.、Maltby Sheena、Normandale Alexa、Garcha Rajvinder、Richter Alex G.、Faustini Sian E.、Lyons Ronan A.、Kee Frank、Shaheen Seif O.、Perdek Natalia、Greenig Matthew、Symons Jane、Pfeffer Paul、Ford David、Sheikh Aziz、Davies Gwyneth A.、Orton Christopher、Holt Hayley、Barlow Nicola L.、Jolliffe David A.、Vivaldi Giulia、Norrie John、Relton Clare、Talaei Mohammad
Barts and The London School of Medicine and Dentistry, Queen Mary University of London||Asthma UK Centre for Applied Research, University of Edinburgh||Health Data Research UK BREATHE Hub, Queen Mary University of LondonBarts and The London School of Medicine and Dentistry, Queen Mary University of London||Asthma UK Centre for Applied Research, University of EdinburghBarts and The London School of Medicine and Dentistry, Queen Mary University of LondonClinical Biochemistry Department, Black Country Pathology Services, City HospitalClinical Biochemistry Department, Black Country Pathology Services, City HospitalInstitute of Immunology and Immunotherapy, College of Medical and Dental Sciences, University of BirminghamInstitute of Immunology and Immunotherapy, College of Medical and Dental Sciences, University of BirminghamPopulation Data Science, Swansea University Medical School||Health Data Research UK BREATHE Hub, Swansea UniversityCentre for Public Health (NI), Queen?ˉs University BelfastBarts and The London School of Medicine and Dentistry, Queen Mary University of LondonBarts and The London School of Medicine and Dentistry, Queen Mary University of LondonBarts and The London School of Medicine and Dentistry, Queen Mary University of LondonJane Symons MediaBarts and The London School of Medicine and Dentistry, Queen Mary University of LondonPopulation Data Science, Swansea University Medical School||Health Data Research UK BREATHE Hub, Swansea UniversityAsthma UK Centre for Applied Research, University of Edinburgh||Usher Institute, University of Edinburgh||Health Data Research UK BREATHE Hub, University of EdinburghAsthma UK Centre for Applied Research, University of Edinburgh||Population Data Science, Swansea University Medical School||Health Data Research UK BREATHE Hub, Swansea UniversityPopulation Data Science, Swansea University Medical School||Health Data Research UK BREATHE Hub, Swansea UniversityBarts and The London School of Medicine and Dentistry, Queen Mary University of London||Asthma UK Centre for Applied Research, University of EdinburghClinical Biochemistry Department, Black Country Pathology Services, City HospitalBarts and The London School of Medicine and Dentistry, Queen Mary University of LondonBarts and The London School of Medicine and Dentistry, Queen Mary University of LondonUsher Institute, University of Edinburgh||Health Data Research UK BREATHE Hub, University of EdinburghBarts and The London School of Medicine and Dentistry, Queen Mary University of LondonBarts and The London School of Medicine and Dentistry, Queen Mary University of London
预防医学医学研究方法医药卫生理论
Griffiths Christopher J.,Martineau Adrian R.,Maltby Sheena,Normandale Alexa,Garcha Rajvinder,Richter Alex G.,Faustini Sian E.,Lyons Ronan A.,Kee Frank,Shaheen Seif O.,Perdek Natalia,Greenig Matthew,Symons Jane,Pfeffer Paul,Ford David,Sheikh Aziz,Davies Gwyneth A.,Orton Christopher,Holt Hayley,Barlow Nicola L.,Jolliffe David A.,Vivaldi Giulia,Norrie John,Relton Clare,Talaei Mohammad.Vitamin D Supplements for Prevention of COVID-19 or other Acute Respiratory Infections: a Phase 3 Randomised Controlled Trial (CORONAVIT)[EB/OL].(2025-03-28)[2025-05-05].https://www.medrxiv.org/content/10.1101/2022.03.22.22271707.点此复制
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