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Trial Title:
Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy
NCT ID:
NCT05887505
Condition:
Hepatocellular Carcinoma
Liver Function
Postoperative Complications
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Postoperative Complications
Vitamin D
Conditions: Keywords:
Vitamin D Supplementation
Hepatectomy
Perioperative
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Vitamin D
Description:
Oral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days
Arm group label:
Vitamin D group
Intervention type:
Other
Intervention name:
Placebo
Description:
Oral supplementation of placebo in 3 consecutive days.
Arm group label:
Placebo Group
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.
Criteria for 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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 9, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Taoyuan General Hospital
Agency class:
Other
Source:
Taoyuan General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05887505
