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

N/ANot Yet RecruitingNCT05887505

Taoyuan General Hospital120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Hepatocellular Carcinoma Liver Function Postoperative Complications

Interventions

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: During the study period

Ratio of liver failure

Time frame: 7 days pre- OP (day -7)

Ratio of liver failure

Time frame: 1 day pre- OP (day -1)

Ratio of liver failure

Time frame: 1 day post- OP (day 1)

Ratio of liver failure

Time frame: 1 day before discharge

Secondary Outcomes

25(OH)D status

Time frame: Baseline (day -7), day -1, day 1 and 1 day before discharge

Prevalence of high PTH

Time frame: Baseline (day -7), day -1, day 1 and 1 day before discharge

Prevalence of hypercalcemia

Time frame: Baseline (day -7), day -1, day 1 and 1 day before discharge

Prevalence of hypomagnesemia

Time frame: Baseline (day -7), day -1, day 1 and 1 day before discharge

30-day mortality

Time frame: day 1 post-OP and 1 day before discharge

Clinical outcomes

Including level of C-reactive protein and white blood cell (WBC) count

Time frame: day 1 post-OP and 1 day before discharge

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.

Time frame: day 1 post-OP and 1 day before discharge

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts