Vitamin D Supplementation and Clinical Outcomes in Severe COVID-19 Patients - Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- number of days on mechanical ventilation
研究概览
简要总结
Single center, open label randomized clinical trial.
Study location: tertiary hospital center (University Hospital Split, Croatia). All COVID-19 patients with positive PCR test admitted to ICU and in need for respiratory support will be eligible for inclusion in this study.
Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test.
Intervention:
All patients included in this study will receive standard of care. Patients randomized into intervention group will be receiving 10 000 IU of cholecalciferol daily. Supplement will be administered orally or via gastric tube during ICU stay or for at least 14 days in case of ICU discharge before day 14. Supplementation will begin within 48 hours of admission to ICU. Supplement will be prepared and administered by experienced nursing staff. For patients receiving supplementation, vitamin D levels will be checked on days 7 and 14. In case that vitamin D levels are > 150 nmol/l or if the calcium levels are consistently > 2.6 mmol/l, further supplementation will be stopped.
Outcomes:
Primary outcome is number of days spent on ventilator.
Secondary outcomes: all-cause mortality on day 28, all-cause mortality on day 60, mortality at hospital discharge, clinical improvement at day 28 (WHO clinical progression scale), days spent in ICU, days spent in hospital after discharge from ICU, need for dialysis at day 28, bacterial superinfections, neutrophile to lymphocyte ratio, disease severity (CRP levels, PaO2/FiO2 ratio, D-dimer levels, fibrinogen, ferritin, PCT), adverse outcomes.
Hypothesis: patients receiving Vitamin D supplementation will have shorter number of days spent on mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, 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
- •Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test.
排除标准
- •Patients will be excluded from study in case of calcium levels that are consistently above normal serum range (> 2.6 mmol/L, > 10.5 mg/dL) or if vitamin D levels are > 150 nmol/L.
结局指标
主要结局
number of days on mechanical ventilation
时间窗: Daily, through study completion, on average 6 months
Number of days spent on mechanical ventilation for each patient
次要结局
- Number of days spent in ICU(Daily, through study completion, on average 6 months)
- Number of days spent in hospital after ICU discharge(Daily, through study completion, on average 6 months)
- clinical improvement at day 28(day 28)
- Acute renal failure(Day 28)
- All-cause mortality on day 60(day 60)
- All-cause mortality on day 28(day 28)
- bacterial superinfections(Daily, through study completion, on average 6 months)
- CRP levels (mg/ml)(Daily, through study completion, on average 6 months)
- prokalcitonin levels (ng/ml)(Daily, through study completion, on average 6 months)
- fibrinogen levels (g/L)(Daily, through study completion, on average 6 months)
- D-dimer levels (mg/l)(Daily, through study completion, on average 6 months)
- adverse outcomes(Daily, through study completion, on average 6 months)
研究者
Lenko Saric
Anesthesiology and Intensive Care specialist
University Hospital of Split