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临床试验/NCT05650268
NCT05650268撤回不适用

Effects of Stoss Therapy of Vitamin D3 on Peri-operative Outcomes in Patients Receiving General Surgery

National Taiwan University Hospital0 个研究点开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

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