Peri-operative Vitamin D Therapy for Hepatectomy

NCT ID: NCT05650151

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-01-31

Brief Summary

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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

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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

Conditions

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Vitamin D Deficiency Hepatocellular Carcinoma Perioperative Complication

Keywords

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Vitamin d therapy Hepatocellular Carcinoma Perioperative Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D group

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_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.

Interventions

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Vitamin D

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients older than 20 years
* Patients will undergo hepatectomy for hepatocellular carcinoma.

Exclusion Criteria

* Patients with hypercalcemia, hyperparathyroidism, sarcoidosis, multiple myeloma
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yin-Yi Han, PHD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Central Contacts

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Yin-Yi Han, PHD

Role: CONTACT

Phone: 886972651405

Email: [email protected]

Other Identifiers

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2022-11-007A

Identifier Type: OTHER

Identifier Source: secondary_id

202209057RINA

Identifier Type: -

Identifier Source: org_study_id