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
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
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
NCT ID
NCT05650151
First Posted
December 6, 2022
Last Updated
December 6, 2022
Sponsor
National Taiwan University Hospital
Collaborators
Taipei Veterans General Hospital, Taiwan
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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