Short Term, High Dose Vitamin D Supplementation in Moderate to Severe COVID-19 Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Sequential Organ Failure Assessment (SOFA)
研究概览
简要总结
COVID-19 caused by SARS-CoV-2 virus has affected the lives of millions of individuals globally and also severely strained the medical community. Pre-symptomatic and asymptomatic SARS-CoV-2 positive individuals far outnumber the symptomatic ones or those with severe disease. The transmission potential of SARS CoV-2 is potentially greater than earlier viral outbreaks of SARS-CoV and MERS-CoV.Routine measures of social distancing, personal hand hygiene and limited outdoor contact activities have shown benefits to limit corona virus infection. However, the role of vitamin D in SARS-CoV-2 infection is sparingly explored despite the knowledge of an immunomodulatory role and protective effect of vitamin D against viral infections. Meta-analysis of five clinical trials of vitamin D supplementation found that those receiving vitamin D supplementation had fewer respiratory tract infections (odds ratio = 0.58 (95%CI, 0.42 - 0.81).Any immune-modulatory effect of vitamin D is likely to be observed at levels which are considered higher than that required for normal bone metabolism.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RT-PCR proven SARS-CoV-2 infection or computed tomography scan findings compatible with the COVID19 disease (bilateral multifocal ground-glass opacities ≥50%)
- •Moderate to severe COVID-19 defined by PFR ratio of <200
- •SOFA score>4
- •Patients with vitamin D deficiency defined as 25 (OH)D level<20 ng/ml
- •Age>18 years
排除标准
- •Vitamin D sufficient or already receiving vitamin D supplements
- •Active malignancy
- •Hypercalcemia, hyperparathyroidism
- •Chronic kidney disease (eGFR<30 ml/min)
- •Pregnant and lactating women
- •Patient on mechanical ventilation at ICU admission
研究组 & 干预措施
Intervention
Vitamn D 6 lakh IU oral stat
干预措施: cholecalciferol 6 lakh IU (Drug)
Placebo
Placebo equal volume/ weight
干预措施: cholecalciferol 6 lakh IU (Drug)
结局指标
主要结局
Sequential Organ Failure Assessment (SOFA)
时间窗: 7 days
Sequential Organ Failure Assessment score at day 7. SOFA score range from 1 to a maximum of 24. A greator score suggests worse outcome.
次要结局
- Sequential Organ Failure Assessment (SOFA) Score(3 days)
- Sequential Organ Failure Assessment (SOFA) score(14 days)
研究者
Ashu Rastogi
Associate Professor
Post Graduate Institute of Medical Education and Research, Chandigarh