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

Last updated: June 4, 2023
Sponsor: Taoyuan General Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Liver Disorders

Liver Cancer

Abdominal Cancer

Treatment

Vitamin D

Placebo

Clinical Study ID

NCT05887505
TYGH111086
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. ≥ 20-year HCC subjects receiving laparoscopic hepatectomy
  • 2.Sign the informed consent

Exclusion

Exclusion Criteria:

    1. Using estrogen drugs, bisphosphonates, or drugs for bone disease.
    1. Consume calcium tablets within 2 weeks before operation
    1. Sarcoidosis, multiple myeloma
    1. Pregnant women or plan to become pregnant within 3 months after surgery
    1. Autoimmune hepatitis (AIH)
    1. Early liver recurrence
    1. Used to participate in other clinical trials

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Vitamin D
Phase:
Study Start date:
June 09, 2023
Estimated Completion Date:
December 31, 2027