The Efficacy of Vitamin D Supplementation in Patients With Severe and Extremely Severe COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Сomplete blood count dynamics 2
研究概览
简要总结
Despite the successful treatment of patients with moderate coronavirus disease 2019 (COVID-19), outcomes for patients with severe disease remain unsatisfactory. In this category of patients, the course of the disease is complicated by the development of acute respiratory distress syndrome (ARDS) and the need for mechanical ventilation in the intensive care unit (ICU). Mortality in this category of patients reaches 85%. The lack of effective treatment for COVID-19 has prompted scientists to look for new strategies to reduce the incidence and severity of COVID-19, disease progression, and mortality.
Disease severity and mortality rates due to COVID-19 infection are greater in the elderly and chronically ill patients, populations at high risk for vitamin D deficiency. Vitamin D plays an important role in immune function and inflammation.
A number of experimental studies have shown that stimulation of vitamin D receptors can improve the course of ARDS due to inhibition of the hyperimmune inflammatory response, regulation of the renin-angiotensin system, modulation of neutrophil activity, maintenance of the integrity of the pulmonary epithelial barrier and stimulation of epithelial repair, as well as by reducing hypercoagulation.
Several studies on ICU patients have reported that low vitamin D (25(OH)D) concentrations are associated with a higher risk of negative outcomes such as death, organ failure, prolonged mechanical ventilation, a higher rate of ventilation-associated pneumonia, and sepsis.
While the available evidence to-date, from largely poor-quality observational studies, may be viewed as showing a trend for an association between low serum 25(OH)D levels and COVID-19 related health outcomes, this relationship was not found to be statistically significant. Calcifediol supplementation may have a protective effect on COVID-19 related ICU admissions.
详细描述
The aim of the study is to evaluate the efficacy of vitamin D (cholecalciferol) supplementation in patients with severe and extremely severe disease caused by the SARS-CoV-2 virus, admitted to an ICU of the COVID-center on the first day and in dynamics until discharge from the hospital or death. Patients with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤ 30 ng/ml] will be randomized to two groups: 1 - patients will receive 60,000 IU of cholecalciferol supplementation; 2 - patients will receive matched placebo.
The demographic and clinical data will be collected. Laboratory data (hemoglobin, lymphocytes, neutrophil to lymphocyte ratio, D-dimer level, Interleukin-6, procalcitonin, ferritin, glucose level, high-sensitive troponin Т, vitamin D level (25(OH)D), acid-base balance, signs of a secondary bacterial infection, immunogram, Von Willebrand factor antigen and Instrumental data (CT-scan, Electrocardiography, echocardiography, arterial and venous ultrasound investigation) will be analysed. The frequency of complications, duration of mechanical ventilation, length of stay in the ICU and in the hospital, and mortality will be evaluated.
This study is single-centre prospective randomized placebo-controlled trial.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with COVID-19 admitted to the ICU with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤ 30 ng/ml]
排除标准
- •less than 24 hours in ICU by any reason
- •chronic decompensated disease with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure) with a life expectancy of less than 48 hours
- •atonic coma
- •allergic reaction on cholecalciferol or herbal oil
结局指标
主要结局
Сomplete blood count dynamics 2
时间窗: Change from baseline on day 15 during ICU treatment
Сomplete blood count
Сomplete blood count dynamics 3
时间窗: Change from baseline on day 21 during ICU treatment
Сomplete blood count
C-reactive protein 2
时间窗: Change from baseline on day 15 during ICU treatment
Concentration of C-reactive protein
Von Willebrand factor antigen
时间窗: Change from baseline on day 7 during ICU treatment
Concentration of Von Willebrand factor antigen
Thrombotic complications
时间窗: 60 days
Arterial or venous thrombotic complications
Сomplete blood count
时间窗: Change from baseline on day 5 during ICU treatment
Сomplete blood count
Сomplete blood count dynamics 1
时间窗: Change from baseline on day 10 during ICU treatment
Сomplete blood count
C-reactive protein
时间窗: Change from baseline on day 5 during ICU treatment
Concentration of C-reactive protein
Infection marker 1
时间窗: Change from baseline on day 10 during ICU treatment
Concentration of Procalcitonin
Proinflammatory marker 1
时间窗: on day 10 during ICU treatment
Concentration of D-dimer
inflammatory marker 1
时间窗: Change from baseline on day 10 during ICU treatment
Concentration of Interleukin-6
inflammatory marker 2
时间窗: Change from baseline on day 15 during ICU treatment
Concentration of Interleukin-6
C-reactive protein 1
时间窗: Change from baseline on day 10 during ICU treatment
Concentration of C-reactive protein
C-reactive protein 3
时间窗: Change from baseline on day 21 during ICU treatment
Concentration of C-reactive protein
Immunogram
时间窗: Change from baseline on day 7 during ICU treatment
The amount of NKT cells (CD3+CD56+CD16+), NK cells (CD3-CD56+CD16+)
inflammatory marker
时间窗: Change from baseline on day 5 during ICU treatment
Concentration of Interleukin-6
Proinflammatory marker
时间窗: Change from baseline on day 5 during ICU treatment
Concentration of D-dimer
Proinflammatory marker 2
时间窗: on day 15 during ICU treatment
Concentration of D-dimer
Proinflammatory marker 3
时间窗: on day 21 during ICU treatment
Concentration of D-dimer
inflammatory marker 3
时间窗: Change from baseline on day 21 during ICU treatment
Concentration of Interleukin-6
Infection marker
时间窗: Change from baseline on day 5 during ICU treatment
Concentration of Procalcitonin
次要结局
- Mortality(60 days)
- Length of stay in the ICU(60 days)
- Infection complications(60 day)
- Length of stay in the hospital(60 days)
- Mechanical ventilation duration(30 days)
- Non-invasive Mechanical ventilation duration(30 days)