MedPath

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

Not Applicable
Withdrawn
Conditions
Vitamin D Deficiency
Surgery
Interventions
Other: 95% MCT
Drug: 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WITHDRAWN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
Inclusion Criteria
  • 20 years or older
  • Adult patients who will receive general surgery
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control group95% MCTThe control group will receive 95% MCT D3\~7 days prior to the surgery.
Vitamin D3Vitamin D3The experimental group will receive 576000 IU in single oral dose of liquid vitamin D3\~7 days prior to the surgery.
Primary Outcome Measures
NameTimeMethod
Mortality rate30 days
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath