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

Taoyuan General Hospital

Status: Not yet enrolling

Conditions: Postoperative Complications; Hepatocellular Carcinoma; Liver Function

Treatments: Other: Placebo; Other: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT05887505

TYGH111086

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Vitamin D group

Experimental group

Description:

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

Treatment:

Other: Vitamin D

Placebo Group

Placebo Comparator group

Description:

Oral supplementation of placebo in 3 days

Treatment:

Other: Placebo