Impact of Zinc and Vitamin D3 Supplementation on the Survival of Institutionalized Aged Patients Infected With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Survival rate in asymptomatic subjects at inclusion
研究概览
简要总结
Mortality from Covid-19 increases with age, reaching 14.8% from the age of 80. The severity of the infection is linked to the acute respiratory distress syndrome (ARDS) which requires intensive care. ARDS is the consequence of the reactional inflammatory storm that damages the lungs.
Aged subjects are particularly prone to zinc and vitamin D deficiency. These two micronutrients are able to modulate the immune response by reducing the inflammatory storm.
The hypothesis is that supplementation with zinc and vitamin D would reduce the inflammatory reaction which worsens ARDS and leads to the death of subjects infected with Covid-19.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Institutionalized
排除标准
- •Life expectancy < 1 month independently of Covid-19 infection (overall subjects)
- •Known hypercalcemia
- •History of renal lithiasis
研究组 & 干预措施
Group supplementation
干预措施: 25-OH cholecalciferol (Dietary Supplement)
Group usual treatment
Group supplementation
干预措施: Zinc gluconate (Dietary Supplement)
结局指标
主要结局
Survival rate in asymptomatic subjects at inclusion
时间窗: Two months after inclusion
次要结局
- Survival rate in overall subjects(Two months after inclusion)
- Cumulative incidence of Covid-19 infection in asymptomatic subjects at inclusion(Within two months after inclusion)
- Survival rate in symptomatic subjects at inclusion(Two months after inclusion)