Vitamin D Supplementation in Patients With COVID-19: A Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Length of hospitalization
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) was declared an emergency public health problem by the World Health Organization (WHO) in March 2020. Since then, several initiatives by the medical and scientific community have sought alternatives to treat infected individuals, as well as identifying risk or protective factors for the contamination and prognosis of patients. In this perspective, vitamin D supplementation can improve some important outcomes in critically ill patients, being considered a potent immunomodulatory agent. Vitamin D deficiency is a common outcome in critically ill patients, thus making it a modifiable risk factor with great potential for reducing hospital stay and intensive care and mortality. The investigators speculate that vitamin D supplementation could have therapeutic effects in patients 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of flu syndrome with hospitalization criteria;
- •Respiratory rate ≥ 24irpm and / or saturation <93% in room air, or belonging to the risk group for complications:
- •Chronic diseases: heart disease, diabetes mellitus, systemic arterial hypertension and neoplasms,
- •Immunosuppression,
- •Pulmonary tuberculosis;
- •Tomographic findings compatible with coronavirus disease.
排除标准
- •Patient admitted already under invasive mechanical ventilation;
- •Patient admitted with severe acute respiratory syndrome and diagnosed with an etiologic agent other than SARS-CoV-2;
- •Prior vitamin D supplementation (above 1000 IU/day);
- •Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl;
- •Admitted patients with expected hospital discharge in less than 24 hours;
- •Patient unable to sign the consent form.
结局指标
主要结局
Length of hospitalization
时间窗: From date of randomization until the date of hospital discharge or death, which is usually less than 1 month
total number of days that patient remained hospitalized
次要结局
- Length of use of mechanic ventilator(From date of randomization until the date of hospital discharge or death, which is usually less than 1 month)
- Number and severity of symptoms(From date of randomization until the date of hospital discharge or death, which is usually less than 1 month)
- Inflammatory markers(Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month))
- C-reactive protein(Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month))
- Vitamin D(Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month))
- Creatinine(Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month))
- Mortality(From date of randomization until the date of hospital discharge or death, which is usually less than 1 month)
- Number of cases admitted to Intensive Care Unit (ICU)(From date of randomization until the date of hospital discharge or death, which is usually less than 1 month)
- Calcium(Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month))
- Physical activity(Baseline)
研究者
ROSA MARIA RODRIGUES PEREIRA
Dr
University of Sao Paulo