search
Back to results

Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy

Primary Purpose

Hepatocellular Carcinoma, Liver Function, Postoperative Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
Taoyuan General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Vitamin D Supplementation, Hepatectomy, Perioperative

Eligibility Criteria

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

Inclusion Criteria: 1. ≥ 20-year HCC subjects receiving laparoscopic hepatectomy 2.Sign the informed consent Exclusion Criteria: 1. Using estrogen drugs, bisphosphonates, or drugs for bone disease. 2. Consume calcium tablets within 2 weeks before operation 3. Sarcoidosis, multiple myeloma 4. Pregnant women or plan to become pregnant within 3 months after surgery 5. Autoimmune hepatitis (AIH) 6. Early liver recurrence 7. Used to participate in other clinical trials

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vitamin D group

    Placebo Group

    Arm Description

    Oral supplementation of 1,728,000 IU vitamin D3 in 3 days

    Oral supplementation of placebo in 3 days

    Outcomes

    Primary Outcome Measures

    Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association
    Ratio of liver failure
    Ratio of liver failure
    Ratio of liver failure
    Ratio of liver failure

    Secondary Outcome Measures

    25(OH)D status
    Prevalence of high PTH
    Prevalence of hypercalcemia
    Prevalence of hypomagnesemia
    30-day mortality
    Clinical outcomes
    Including level of C-reactive protein and white blood cell (WBC) count
    Complications after surgery
    Including in-hospital infectious complications, Dindo-Clavien classification, volume of ascites, duration of ascites, intra-abdominal abscess, postoperative haemorrhage, pleural effusion, wall abscess, and eventration.

    Full Information

    First Posted
    May 2, 2023
    Last Updated
    June 4, 2023
    Sponsor
    Taoyuan General Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05887505
    Brief Title
    Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy
    Official Title
    Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 9, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2027 (Anticipated)
    Study Completion Date
    December 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taoyuan General 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
    High concentrations of parathyroid hormone (PTH) are common in patients with hepatocellular carcinoma (HCC). This study is aimed to investigate effects of vitamin D status and its multiple mega-dosage supplementation on PTH and clinical outcomes in HCC patients before and after hepatectomy. It's a single-center, prospective, parallel, double-blind, placebo-controlled study for 120 eligible subjects. The subjects will receive consecutively 3-day intervention treatments from 7th day before surgery. 30-day postoperative mortality, postoperative complications, and laboratory data will be evaluated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma, Liver Function, Postoperative Complications
    Keywords
    Vitamin D Supplementation, Hepatectomy, Perioperative

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin D group
    Arm Type
    Experimental
    Arm Description
    Oral supplementation of 1,728,000 IU vitamin D3 in 3 days
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    Oral supplementation of placebo in 3 days
    Intervention Type
    Other
    Intervention Name(s)
    Vitamin D
    Intervention Description
    Oral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Oral supplementation of placebo in 3 consecutive days.
    Primary Outcome Measure Information:
    Title
    Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association
    Time Frame
    During the study period
    Title
    Ratio of liver failure
    Time Frame
    7 days pre- OP (day -7)
    Title
    Ratio of liver failure
    Time Frame
    1 day pre- OP (day -1)
    Title
    Ratio of liver failure
    Time Frame
    1 day post- OP (day 1)
    Title
    Ratio of liver failure
    Time Frame
    1 day before discharge
    Secondary Outcome Measure Information:
    Title
    25(OH)D status
    Time Frame
    Baseline (day -7), day -1, day 1 and 1 day before discharge
    Title
    Prevalence of high PTH
    Time Frame
    Baseline (day -7), day -1, day 1 and 1 day before discharge
    Title
    Prevalence of hypercalcemia
    Time Frame
    Baseline (day -7), day -1, day 1 and 1 day before discharge
    Title
    Prevalence of hypomagnesemia
    Time Frame
    Baseline (day -7), day -1, day 1 and 1 day before discharge
    Title
    30-day mortality
    Time Frame
    day 1 post-OP and 1 day before discharge
    Title
    Clinical outcomes
    Description
    Including level of C-reactive protein and white blood cell (WBC) count
    Time Frame
    day 1 post-OP and 1 day before discharge
    Title
    Complications after surgery
    Description
    Including in-hospital infectious complications, Dindo-Clavien classification, volume of ascites, duration of ascites, intra-abdominal abscess, postoperative haemorrhage, pleural effusion, wall abscess, and eventration.
    Time Frame
    day 1 post-OP and 1 day before discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. ≥ 20-year HCC subjects receiving laparoscopic hepatectomy 2.Sign the informed consent Exclusion Criteria: 1. Using estrogen drugs, bisphosphonates, or drugs for bone disease. 2. Consume calcium tablets within 2 weeks before operation 3. Sarcoidosis, multiple myeloma 4. Pregnant women or plan to become pregnant within 3 months after surgery 5. Autoimmune hepatitis (AIH) 6. Early liver recurrence 7. Used to participate in other clinical trials
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuan-Hao Ku, MD
    Phone
    +886-3 3699721
    Ext
    4208
    Email
    darkbravo@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy

    We'll reach out to this number within 24 hrs