Phase 3 Randomised Controlled Trial of Vitamin D Supplementation to Reduce Risk and Severity of COVID-19 and Other Acute Respiratory Infections in the UK Population

简要总结

主要结局

次要结局

• Proportion of participants developing PCR- or antigen test-positive COVID-19(Over 6 months)
• Proportion of participants dying of any cause during participation in the trial(Over 6 months)
• Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection(Over 6 months)
• Proportion of participants with COPD who experience one or more exacerbations of COPD requiring treatment with oral corticosteroids and/or antibiotics, and/or requiring hospital treatment(Over 6 months)
• Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation(Over 6 months)
• Proportion of participants experiencing a serious adverse event of any cause(Over 6 months)
• Proportion of participants dying of acute respiratory infection during participation in the trial(Over 6 months)
• Proportion of participants with asthma who experience one or more exacerbations of asthma requiring treatment with oral corticosteroids and/or requiring hospital treatment(Over 6 months)
• Mean MRC dyspnoea score at the end of the study in people who have had PCR-, antigen test- or antibody test-confirmed SARS-CoV-2 infection and who report symptoms of COVID-19 lasting more than 4 weeks after onset(6 months)
• Proportion of participants hospitalised for COVID-19 requiring ventilatory support(Over 6 months)
• Proportion of SARS-CoV-2 vaccinated participants with antibodies to SARS-CoV-2 spike protein(Over 6 months)
• Proportion of participants who have had PCR-, antigen test- or antibody test-confirmed SARS-CoV-2 infection who report symptoms of COVID-19 lasting more than 4 weeks after onset(Over 6 months)
• Proportion of participants who experience COVID-19 requiring hospitalisation(Over 6 months)
• Proportion of participants experiencing known hypercalcaemia(Over 6 months)
• Frequency of antigen-specific T cells reacting to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants (sub-set of participants)(Over 6 months)
• Mean COVID-19 Recovery Questionnaire score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection and who report symptoms of COVID-19 lasting more than 4 weeks after onset(6 months)
• Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation(Over 6 months)
• Mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status)(6 months)
• Mean FACIT Fatigue Scale score at the end of the study in people with antigen test- or antibody test-confirmed SARS-CoV-2 infection and who report symptoms of COVID-19 lasting more than 4 weeks after onset(6 months)
• Proportion of SARS-CoV-2 vaccinated participants with antigen-specific T cell responses to SARS-CoV-2 spike protein (sub-set of participants)(Over 6 months)
• Proportion of participants dying of COVID-19 during participation in the trial(Over 6 months)
• Median titre of antibodies to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants(Over 6 months)