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

National Taiwan University

Status: Withdrawn

Conditions: Vitamin D Deficiency; Surgery

Treatments: Other: 95% MCT; Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT05650268

201808006RIPC

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Vitamin D3

Experimental group

Description:

The experimental group will receive 576000 IU in single oral dose of liquid vitamin D3\~7 days prior to the surgery.

Treatment:

Drug: Vitamin D3

Control group

Placebo Comparator group

Description:

The control group will receive 95% MCT D3\~7 days prior to the surgery.

Treatment:

Other: 95% MCT