Effect of Vitamin D Administration on Prevention and Treatment of Mild Forms of Suspected Covid-19
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Composite of cumulative death (i.e. mortality) for all causes and for specific causes.
研究概览
简要总结
The new outbreak of the SARS-CoV-2 coronavirus is causing an important pandemic affecting a large number of people all-over the world. Vitamin D is a hormone precursor produced by our own body with the help of sunlight which has an important role on adaptive immunity and cellular differentiation, maturation and proliferation of several immune cells. Reduced levels of vitamin D in calves were positioned as the main cause of bovine coronavirus infection in the past. Therefore, it seems plausible that the use of vitamin D as a nutritional ergogenic aid could be a potential intervention to fight against COVID-19 infected patients which remain asymptomatic or which have non-severe and severe symptoms. This study aims to investigate whether the use of vitamin D as an immune modulator agent induces significant improvements of health status and outcomes in non-severe symptomatic patients infected with COVID-19 as well as preventing COVID-19 health deterioration. We hypothesize that vitamin D will significantly improve hard endpoints related to COVID-19 deleterious consequences compared with a usual care control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-severe symptomatic patients who present cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia or alternative signs of respiratory infections.
排除标准
- •Patients presenting severe respiratory and/or multisystemic symptoms compatible with advanced COVID-19 and intercurrent acute or severe chronic diseases (i.e. active cancer).
结局指标
主要结局
Composite of cumulative death (i.e. mortality) for all causes and for specific causes.
时间窗: Through study completion, an average of 10 weeks
次要结局
- Necessity of invasive assisted ventilation(Through study completion, an average of 10 weeks)
- Necessity of non-invasive assisted ventilation(Through study completion, an average of 10 weeks)
- Intensive care unit admission(Through study completion, an average of 10 weeks)
- Post-anesthesia care unit admission(Through study completion, an average of 10 weeks)
- Hospital admission(Through study completion, an average of 10 weeks)
- Medical consultation(Through study completion, an average of 10 weeks)
- Home care and isolation time(Through study completion, an average of 10 weeks)
- Bed rest time(Through study completion, an average of 10 weeks)
- symptoms' duration (i.e. cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia, diarrhea or alternative signs of COVID-19)(Through study completion, an average of 10 weeks)
- Subjective perception of recovery(Through study completion, an average of 10 weeks)
研究者
Manuel Castillo Garzón
MD, PhD
Universidad de Granada