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

Primary Purpose

Vitamin D Deficiency, Surgery

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin D3
95% MCT
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vitamin D3

    Control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Mortality rate

    Secondary Outcome Measures

    Full Information

    First Posted
    July 26, 2021
    Last Updated
    December 13, 2022
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05650268
    Brief Title
    Effects of Stoss Therapy of Vitamin D3 on Peri-operative Outcomes in Patients Receiving General Surgery
    Official Title
    Effects of Stoss Therapy of Vitamin D3 on Peri-operative Outcomes in Patients Receiving General Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Because of impact from COVID-19 pandemic
    Study Start Date
    September 1, 2021 (Actual)
    Primary Completion Date
    April 1, 2022 (Actual)
    Study Completion Date
    April 30, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin D Deficiency, Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin D3
    Arm Type
    Experimental
    Arm Description
    The experimental group will receive 576000 IU in single oral dose of liquid vitamin D3~7 days prior to the surgery.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    The control group will receive 95% MCT D3~7 days prior to the surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin D3
    Other Intervention Name(s)
    Vitamin D
    Intervention Description
    Receiving 576000 international units in single oral dose of liquid vitamin D 3~7 days prior to the surgery.
    Intervention Type
    Other
    Intervention Name(s)
    95% MCT
    Intervention Description
    95% MCT supplement 3-7 day before surgery
    Primary Outcome Measure Information:
    Title
    Mortality rate
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yin-Yi Han, MD,PhD
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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