Effects of Stoss Therapy of Vitamin D3 on Peri-operative Outcomes in Patients Receiving General Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Mortality rate
研究概览
简要总结
To investigate whether preoperative supplement with high-dose vitamin D3 can reduce the perioperative risk and enhance recovery
详细描述
Perioperative management for risk reduction in patients undergoing major surgery are taken increasingly important nowadays. The patient factor (age and comorbidities mainly), type of surgery and extent of tissue injury are major contributions to the development perioperative complications. From nutrition support to nutrition therapy, a comprehensive nutrition plays a pivotal role to optimize the above three key factors and hence reduce the perioperative risk. Vitamin D, a pleiotropic hormone with extensive physiological effect, is one of the nutrients critical to perioperative outcomes. It not only meets the essential demand of surgical patients, such as wound care, infection control, metabolic support and organ support, but also attenuates oxidative stress, modulates dys-inflammation and repair the damaged organelles like telomere and mitochondria. This is a double-blind, randomized controlled trial in a single center. Sixty eligible adult patients who will undergo general surgery are to be included.
The experimental group will receive 576000 IU in single oral dose of liquid vitamin D 3~7 days prior to the surgery. The primary endpoint is rapid recovery index, such as bowel recovery, pain control, sedation and fatigue assessment. The secondary endpoints include perioperative inflammatory indexes, hemodynamic parameters, glycemic control as well as safety evaluation of vitamin D.
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
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years or older
- •Adult patients who will receive general surgery
排除标准
- •Chronic liver diseases
- •Hypercalcemia
- •Using estrogen drug, bisphosphonate, other durgs to treat bone diseases
- •Sarcoidosis, Multiple myeloma or Primary hyperparathyroidism
- •Pregnant women
- •Other trial participation
研究组 & 干预措施
Vitamin D3
The experimental group will receive 576000 IU in single oral dose of liquid vitamin D3~7 days prior to the surgery.
干预措施: Vitamin D3 (Drug)
Control group
The control group will receive 95% MCT D3~7 days prior to the surgery.
干预措施: 95% MCT (Other)
结局指标
主要结局
Mortality rate
时间窗: 30 days
次要结局
未报告次要终点
