Effects of Stoss Therapy of Vitamin D3 on Peri-operative Outcomes in Patients Receiving General Surgery
- Conditions
- Vitamin D DeficiencySurgery
- Interventions
- Other: 95% MCTDrug: Vitamin D3
- Registration Number
- NCT05650268
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
To investigate whether preoperative supplement with high-dose vitamin D3 can reduce the perioperative risk and enhance recovery
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 20 years or older
- Adult patients who will receive general surgery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group 95% MCT The control group will receive 95% MCT D3\~7 days prior to the surgery. Vitamin D3 Vitamin D3 The experimental group will receive 576000 IU in single oral dose of liquid vitamin D3\~7 days prior to the surgery.
- Primary Outcome Measures
Name Time Method Mortality rate 30 days
- Secondary Outcome Measures
Name Time Method