Peri-operative Vitamin D Therapy for Hepatectomy

National Taiwan University Hospital200 enrolled

Overview

The goal of this double-blind, randomized controlled trial is to test the effect of short-term and high-dose vitamin D therapy in patients undergoing hepatectomy for hepatocellular carcinoma.

Participants will receive short-term high dose of vitamin D during perioperative period. The main questions the study aims to answer are: 1. If vitamin D therapy benefits perioperative care 2. If short-term high dose of vitamin D supplement is safe

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Vitamin D Deficiency Hepatocellular Carcinoma Perioperative Complication

Interventions

Vitamin DDIETARY_SUPPLEMENT

576 000 IU D 5-7 days prior to the surgery and 144 000 IU daily on post-operative day 1-2

PlaceboDIETARY_SUPPLEMENT

An equal volume of medium chain triglyceride (MCT, as placebo) to vitamin D 5-7 days prior to the surgery and on the post-operative day 1-2.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients older than 20 years * Patients will undergo hepatectomy for hepatocellular carcinoma. Exclusion Criteria: * Patients with hypercalcemia, hyperparathyroidism, sarcoidosis, multiple myeloma

Outcomes

Primary Outcomes

Infection rate

Diagnosed by clinical presentation and relevant biomarker

Time frame: Perioperative period

Central Contacts

Yin-Yi Han, PHD

CONTACT

886972651405 yyhan@ntuh.gov.tw

Data from ClinicalTrials.gov

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