Peri-operative Vitamin D Therapy for Hepatectomy | NCT05650151

Studies
Peri-operative Vitamin D Therapy for Hepatectomy

NCT05650151

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Dec 14, 2022Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Vitamin D Deficiency
Hepatocellular Carcinoma
Perioperative Complication

Interventions

Vitamin D
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2022-11-007A	Other Identifier	Taipei veterans general hospital

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Estimated

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Jan 31, 2024Estimated

First Submitted Date

Dec 6, 2022

First Submission Date that Met QC Criteria

Dec 6, 2022

First Posted Date

Dec 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2022

Last Update Posted Date

Dec 14, 2022Actual

Name	Class
Taipei Veterans General Hospital, Taiwan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D group	Experimental		Dietary Supplement: Vitamin D
Control group	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Dietary Supplement	576 000 IU D 5-7 days prior to the surgery and 144 000 IU daily on post-operative day 1-2	Vitamin D group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infection rate	Diagnosed by clinical presentation and relevant biomarker	Perioperative period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with hypercalcemia, hyperparathyroidism, sarcoidosis, multiple myeloma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yin-Yi Han, PHD	Contact	886972651405		yyhan@ntuh.gov.tw

Overall Officials

Name	Affiliation	Role
Yin-Yi Han, PHD	National Taiwan University Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided