Effect of Vitamin D in Burn Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Incidence of postoperative complications
研究概览
简要总结
The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.
详细描述
Vitamin D deficiency often occurs in burn patients, which may include longer hospitalization and respiratory and cardiac complications.
The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •vitamin D <30 ng/ml
- •patients undergoing burn surgery
排除标准
- •age < 18 years old
- •hypercalcemia
- •renal disease
- •cardiac disease ( EF<40%, MI, angina)
- •respiratory disease (ARDS, pneumonia)
- •intubated patients
- •electrical burn
研究组 & 干预措施
Vitamin D group
Vitamin D 200,000 IU (1 cc) IM
干预措施: Vitamin D (Biological)
Control group
Normal saline 1 cc IM
干预措施: Vitamin D (Biological)
结局指标
主要结局
Incidence of postoperative complications
时间窗: Within postoperative 1 month
Infection, cardiovascular complication, gastrointestinal complication, respiratory complication, renal complication, and death
次要结局
- Vitamin D level(Within postoperative 14 days)
研究者
Hee Yeong Kim
Assistant Professor
Hangang Sacred Heart Hospital