Effect of vitamin D administration in critically ill vitamin D deficient patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Effect of single high dose vitamin D supplementation as compared to placebo on the outcome of vitamin D deficient patients admitted to PICU i.e. difference in: -
研究概览
简要总结
Overthe last several years, multiple studies have demonstrated that vitamin Ddeficiency is a preexisting and acquired disorder in critical illness, and itsprevalence is probably greater than once believed.50-84% of PICUpatients may have vitamin D deficiency.
Vitamin D deficiency has been thought not only to be commonbut also a potentially modifiable risk factor for severity and clinical outcomeduring critical illness. Even a subclinicalVitamin D deficient state may predispose to neurologic, cardiovascular,respiratory and immune pathology and these organ systems are vital for earlyrecovery.
However, there isvery little literature available to support the use of vitamin D supplementationto improve morbidity and mortality in patients admitted to ICU and vitamin Ddeficiency is rarely replaced adequately, if at all, in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •All the children 1month to 12 years of age requiring PICU admission, who are vitamin D deficient.
排除标准
- •Children with hypocalcaemia, known renal disease, urolithiasis or nephrocalcinosis, parathyroid disease or pituitary dysfunction.
结局指标
主要结局
Effect of single high dose vitamin D supplementation as compared to placebo on the outcome of vitamin D deficient patients admitted to PICU i.e. difference in: -
时间窗: 72 hours
Mortality
时间窗: 72 hours
Duration of PICU stay
时间窗: 72 hours
Need for mechanical ventilation
时间窗: 72 hours
Duration of ventilation in ventilated patients
时间窗: 72 hours
Need for cardiovascular support as boluses or inotropes.
时间窗: 72 hours
次要结局
- Change in vitamin D levels after giving single high dose vitamin D supplementation in critically ill vitamin D deficient children(72 hours)