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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05650268
• Other study ID #: 201808006RIPC
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D3
Receiving 576000 international units in single oral dose of liquid vitamin D 3~7 days prior to the surgery.

Other:
• 95% MCT
95% MCT supplement 3-7 day before surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate		30 days