Peri-operative Vitamin D Therapy for Hepatectomy
Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05650151
Collaborator
Taipei Veterans General Hospital, Taiwan (Other)
200
2
13
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Anticipated Enrollment
:
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Peri-operative Vitamin D Therapy for Patients With Hepatocellular Carcinoma Receiving Hepatectomy
Anticipated Study Start Date
:
Jan 1, 2023
Anticipated Primary Completion Date
:
Dec 31, 2023
Anticipated Study Completion Date
:
Jan 31, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vitamin D group
|
Dietary Supplement: Vitamin D
576 000 IU D 5-7 days prior to the surgery and 144 000 IU daily on post-operative day 1-2
|
| Placebo Comparator: Control group
|
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.
|
Outcome Measures
Primary Outcome Measures
- Infection rate [Perioperative period]
Diagnosed by clinical presentation and relevant biomarker
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- National Taiwan University Hospital
- Taipei Veterans General Hospital, Taiwan
Investigators
- Principal Investigator: Yin-Yi Han, PHD, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05650151
Other Study ID Numbers:
- 202209057RINA
- 2022-11-007A
First Posted:
Dec 14, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms: