Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma (VDHCC)

May 19, 2016 updated by: Yutian Chong, Third Affiliated Hospital, Sun Yat-Sen University

Study of Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B

The purpose of this study is to determine whether vitamin D is effective in the prevention of hepatocellular carcinoma in those patients with chronic hepatitis B.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Potential participants will be identified from the follow-up cohort of chronic hepatitis B in the third Affiliated Hospital of Sun Yat-sen University (3rd SYSU). The hepatologists at the 3rd SYSU's Infectious Disease Institute will ask each potential participant if she/he is interested in participating. If the patient expresses an interest in the study, one of the researchers will meet with the patient when he/she is at the 3rd SYSU for a regular appointment and will describe the study to the potential participant. If a patient continues to be interested in participating, she/he will be given a copy of the review board approved consent document to read. The consent document will be used as a guide for explaining the study in detail to the patient. The participant allocated to the experimental group will be contacted by one of the investigators on the research team and instructed to begin taking 2 tablets per day (800 IU total) of vitamin D3 besides their regular anti-virus treatment. Those patients allocated in the control group will be informed that they are not to take any vitamin D3 and they will be followed as controls for this study. The researcher will investigate general treatment benefits and the potential to reduce the development of Hepatocellular carcinoma (HCC), also known as liver cancer. Improvement of treatment benefits will be determined by interviews with patients, the level of HBsAg and HBeAg, the development of liver fibrosis and evidence of HCC on routine imaging.

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All subjects between the ages of 18 and 70 with chronic hepatitis B and under the oral anti-virus treatment followed at the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, will be offered entry into this study. The diagnosis of chronic Hepatitis B will be based on that they had been positive for hepatitis B surface antigen (HBsAg) for at least six months, and were positive for HBeAg or negative for HBeAg with detectable HBV DNA at screening.
  • No evidence of HCC on entry imaging study.
  • Model for End Stage Liver Disease (MELD) score under 22 (a MELD score over 22 would predict a 3 month mortality rate of approximately 20%).
  • Not currently participating in another intervention study.
  • Not pregnant or lactating, and willing to use effective contraception during study period.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Ability to provide written informed consent according to national/local regulations.

Exclusion Criteria:

  • evidence of hepatocellular carcinoma within 6 months after enrollment,
  • a serum alanine aminotransferase level more than 10 times the upper limit of normal,
  • an elevated serum creatinine level,
  • any diagnosis of kidney stones,
  • a diagnosis of hyperparathyroidism or other serious disturbance of calcium metabolism in the past 5 years,
  • any evidence of autoimmune hepatitis, coinfection with hepatitis C or D virus or human immunodeficiency virus,
  • other serious concurrent illness (e.g., alcoholism, uncontrolled diabetes, or cancer),
  • treatment with immunomodulatory within the 6 months before screening,
  • treatment with any investigational drug within the 30 days before the study began.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D
Drug: Vitamin D3 800 IU daily besides the anti-virus treatment with nucleos(t)ide medicine
Drug: Vitamin D3
Participants with chronic hepatitis B will take 800 IU of vitamin D3 per day by mouth besides the anti-virus treatment with nucleos(t)ide medicine
No Intervention: Control
chronic hepatitis B patients with long term anti-virus therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum levels of 25-hydroxy vitamin D
Time Frame: at baseline, and at 6 and 12 months
Change in serum levels of 25-hydroxyvitamin D at 6 months and 12 months compared to baseline
at baseline, and at 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum creatinine
Time Frame: at baseline, and at 6 and 12 months
Change in serum creatinine at 6 months and at 12 months compared to baseline
at baseline, and at 6 and 12 months
Change in fibrosis score
Time Frame: at baseline, and at 6 and 12 months
Change in fibrosis score at 6 months and at 12 months compared to baseline. The investigators use Fibroscan to get the score of fibrosis.
at baseline, and at 6 and 12 months
Number of participants on Vitamin D treatment with adverse events
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Yutian Chong, MD, Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-CYT-VD5010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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