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Peri-operative Vitamin D Therapy for Hepatectomy

Primary Purpose

Vitamin D Deficiency, Hepatocellular Carcinoma, Perioperative Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin D
Placebo
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 focused on measuring Vitamin d therapy, Hepatocellular Carcinoma, Perioperative Complication

Eligibility Criteria

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

Inclusion Criteria: Patients older than 20 years Patients will undergo hepatectomy for hepatocellular carcinoma. Exclusion Criteria: Patients with hypercalcemia, hyperparathyroidism, sarcoidosis, multiple myeloma

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vitamin D group

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Infection rate
    Diagnosed by clinical presentation and relevant biomarker

    Secondary Outcome Measures

    Full Information

    First Posted
    December 6, 2022
    Last Updated
    December 6, 2022
    Sponsor
    National Taiwan University Hospital
    Collaborators
    Taipei Veterans General Hospital, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05650151
    Brief Title
    Peri-operative Vitamin D Therapy for Hepatectomy
    Official Title
    Peri-operative Vitamin D Therapy for Patients With Hepatocellular Carcinoma Receiving Hepatectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    January 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital
    Collaborators
    Taipei Veterans General Hospital, Taiwan

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this double-blind, randomized controlled trial is to test the effect of short-term and high-dose vitamin D therapy in patients undergoing hepatectomy for hepatocellular carcinoma.
    Detailed Description
    Participants will receive short-term high dose of vitamin D during perioperative period. The main questions the study aims to answer are: If vitamin D therapy benefits perioperative care If short-term high dose of vitamin D supplement is safe

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin D Deficiency, Hepatocellular Carcinoma, Perioperative Complication
    Keywords
    Vitamin d therapy, Hepatocellular Carcinoma, Perioperative Complication

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin D group
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin D
    Intervention Description
    576 000 IU D 5-7 days prior to the surgery and 144 000 IU daily on post-operative day 1-2
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    An equal volume of medium chain triglyceride (MCT, as placebo) to vitamin D 5-7 days prior to the surgery and on the post-operative day 1-2.
    Primary Outcome Measure Information:
    Title
    Infection rate
    Description
    Diagnosed by clinical presentation and relevant biomarker
    Time Frame
    Perioperative period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients older than 20 years Patients will undergo hepatectomy for hepatocellular carcinoma. Exclusion Criteria: Patients with hypercalcemia, hyperparathyroidism, sarcoidosis, multiple myeloma
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yin-Yi Han, PHD
    Phone
    886972651405
    Email
    yyhan@ntuh.gov.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yin-Yi Han, PHD
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Peri-operative Vitamin D Therapy for Hepatectomy

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