A Randomized Controlled Clinical Trial of Oral Vitamin D2 for the Prevention of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Change in incidence of laboratory-confirmed (or COVID-19 antibody test) COVID-19 infection
研究概览
简要总结
A total of 218 participants will be included in this study, and will be randomly assigned 1:1 to the group taking vitamin D2 and the group not taking vitamin D2. Participants in the group taking vitamin D2 orally will receive 200,000 IU of vitamin D2 on the first day of the trial, and again two weeks later (200,000 IU) . The group that will not receive vitamin D2 will not receive any intervention. The whole trial will laste four weeks.
详细描述
This study is a randomized controlled multicenter clinical trial. Participants who meet the inclusion criteria can be included in this trial after signing informed consent. A total of 218 participants will be included in this study, and will be randomly assigned 1:1 to the group taking vitamin D2 and the group not taking vitamin D2. Participants in the group taking vitamin D2 orally will receive 200,000 IU of vitamin D2 on the first day of the trial, and again two weeks later (200,000 IU) . The group that will not receive vitamin D2 will not receive any intervention. The whole trial will laste four weeks. Throughout the trial, participants' nucleic acid or antigen results, 25(OH)D concentrations, etc., need to be tested.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to participate in the clinical study and sign the informed consent;
- •Staff members of Peking University Third Hospital, including the hospital headquarters, Capital International Airport Hospital, North Hospital, Beijing Haidian Hospital, Peking University Third Hospital Yanqing Hospital and Peking University Third Hospital Chongli Hospital;
- •Test negative for COVID-19 antigen and have no symptoms related to COVID-19.
排除标准
- •Hospital staff with serious underlying diseases;
- •Pregnant and lactating women;
- •Long-term vegetarians;
- •Long-term chronic diarrhea, history of subtotal gastrectomy, biliary obstructive disease and pancreatic disease.
研究组 & 干预措施
vitamin D2
Oral dose of Vitamin D2 every two weeks
干预措施: Vitamin D2 (Drug)
Placebo
Without any intervention
干预措施: placebo (Other)
结局指标
主要结局
Change in incidence of laboratory-confirmed (or COVID-19 antibody test) COVID-19 infection
时间窗: 4 weeks
The test will be nucleic acid or antigen testing twice a week for four weeks
次要结局
- The duration of a positive to negative antigen test after infection with COVID-19(up to 4 weeks)
- The duration of symptoms in COVID-19 positive participants(up to 4 weeks)
- The proportion of participants whose symptoms of COVID-19 infection were confirmed by antigen testing for more than 7 days(4 weeks)
- The proportion of asymptomatic COVID-19 infected persons (those who test positive for the etiology of COVID-19 but have no related clinical manifestations)(4 weeks)