NCT05650151Not yet recruitingNot Applicable
Peri-operative Vitamin D Therapy for Patients With Hepatocellular Carcinoma Receiving Hepatectomy
National Taiwan University Hospital0 sites200 target enrollmentStarted: January 1, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 200
- Primary Endpoint
- Infection rate
Study Overview
Brief Summary
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.
Detailed Description
Participants will receive short-term high dose of vitamin D during perioperative period.
The main questions the study aims to answer are:
- If vitamin D therapy benefits perioperative care
- If short-term high dose of vitamin D supplement is safe
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients older than 20 years
- •Patients will undergo hepatectomy for hepatocellular carcinoma.
Exclusion Criteria
- •Patients with hypercalcemia, hyperparathyroidism, sarcoidosis, multiple myeloma
Arms & Interventions
Vitamin D group
Experimental
Intervention: Vitamin D (Dietary Supplement)
Control group
Placebo Comparator
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Infection rate
Time Frame: Perioperative period
Diagnosed by clinical presentation and relevant biomarker
Secondary Outcomes
No secondary outcomes reported
Investigators
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