NCT04579640已完成3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6,200
- 试验地点
- 1
- 主要终点
- Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause.
研究概览
简要总结
CORONAVIT is an open-label, phase 3, randomised clinical trial testing whether implementation of a test-and-treat approach to correction of sub-optimal vitamin D status results in reduced risk and/or severity of COVID-19 and other acute respiratory infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •UK resident
- •Age ≥16 years
- •Gives informed consent to participate
排除标准
- •taking digoxin, alfacalcidol, calcitriol, dihydrotachysterol or paricalcitol
- •known diagnosis of sarcoidosis, primary hyperparathyroidism, renal stones or renal failure requiring dialysis
- •known allergy to any ingredient in the study capsules (vitamin D, olive oil, caramel, gelatine or glycerol)
研究组 & 干预措施
Control
No Intervention
Standard of care (national recommendation of 400 IU/day vitamin D)
Intervention: Higher-dose vitamin D
Experimental
Offer of a daily dose of 3200 IU (80 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level <75 nmol/L
干预措施: Vitamin D (Dietary Supplement)
Intervention: Lower-dose vitamin D
Experimental
Offer of a daily dose of 800 IU (20 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level <75 nmol/L
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause.
时间窗: Over 6 months
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 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 participants dying of acute respiratory infection during participation in the trial(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 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)
- 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)
- 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)
研究者
研究点 (1)
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