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

Study Overview
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Brief Summary
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To investigate whether preoperative supplement with high-dose vitamin D3 can reduce the perioperative risk and enhance recovery

Detailed Description
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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.

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

Conditions
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Vitamin D Deficiency, Surgery

Intervention / Treatment
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* Drug: Vitamin D3
* Other: 95% MCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 years or older Adult patients who will receive general surgery Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3<br>The experimental group will receive 576000 IU in single oral dose of liquid vitamin D3 7 days prior to the surgery. | Drug: Vitamin D3<br>* Receiving 576000 international units in single oral dose of liquid vitamin D 3 7 days prior to the surgery.<br>* Other names: Vitamin D;|
| Placebo Comparator: Control group<br>The control group will receive 95% MCT D3 7 days prior to the surgery. | Other: 95% MCT<br>* 95% MCT supplement 3-7 day before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate |  | 30 days |