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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05650268
Collaborator
(none)
0
Enrollment
2
Arms
7.9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin D3
  • Other: 95% MCT
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Stoss Therapy of Vitamin D3 on Peri-operative Outcomes in Patients Receiving General Surgery
Actual Study Start Date :
Sep 1, 2021
Actual Primary Completion Date :
Apr 1, 2022
Actual Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vitamin D3

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

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

    		•
    Placebo Comparator: Control group

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Mortality rate [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Yin-Yi Han, MD,PhD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05650268
    Other Study ID Numbers:
    • 201808006RIPC
    First Posted:
    Dec 14, 2022
    Last Update Posted:
    Dec 14, 2022
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vitamin D Deficiency
    Vitamin D
    Ergocalciferols
    Cholecalciferol
    Vitamins

    Study Results

    No Results Posted as of Dec 14, 2022