NCT05650151

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

December 14, 2022

Status Verified

November 1, 2022

Enrollment Period

12 months

First QC Date

December 6, 2022

Last Update Submit

December 6, 2022

Conditions

Vitamin D DeficiencyHepatocellular CarcinomaPerioperative Complication

Keywords

Vitamin d therapyHepatocellular CarcinomaPerioperative Complication

Outcome Measures

Primary Outcomes (1)

  • Infection rate

    Diagnosed by clinical presentation and relevant biomarker

    Perioperative period

Study Arms (2)

Vitamin D group

EXPERIMENTAL
Dietary Supplement: Vitamin D

Control group

PLACEBO COMPARATOR
Dietary Supplement: Placebo

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

Vitamin D group
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.

Control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with hypercalcemia, hyperparathyroidism, sarcoidosis, multiple myeloma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitamin D DeficiencyCarcinoma, Hepatocellular

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yin-Yi Han, PHD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yin-Yi Han, PHD

CONTACT

886972651405yyhan@ntuh.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 14, 2022

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

January 31, 2024

Last Updated

December 14, 2022

Record last verified: 2022-11