Back to results

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

Primary Purpose

Hepatitis B, Carcinoma, Hepatocellular

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Vitamin D3

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring vitamin D treatment, chronic hepatitis B

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vitamin D

Control

Arm Description

Drug: Vitamin D3 800 IU daily besides the anti-virus treatment with nucleos(t)ide medicine

chronic hepatitis B patients with long term anti-virus therapy

Outcomes

Primary Outcome Measures

Change in serum levels of 25-hydroxy vitamin D

Change in serum levels of 25-hydroxyvitamin D at 6 months and 12 months compared to baseline

Secondary Outcome Measures

Change in serum creatinine

Change in serum creatinine at 6 months and at 12 months compared to baseline

Change in fibrosis score

Change in fibrosis score at 6 months and at 12 months compared to baseline. The investigators use Fibroscan to get the score of fibrosis.

Number of participants on Vitamin D treatment with adverse events

Full Information

NCT ID

NCT02779465

First Posted

May 13, 2016

Last Updated

May 19, 2016

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT02779465

Brief Title

Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma

Acronym

VDHCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 2016 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B, Carcinoma, Hepatocellular

Keywords

vitamin D treatment, chronic hepatitis B

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D

Arm Type

Experimental

Arm Description

Drug: Vitamin D3 800 IU daily besides the anti-virus treatment with nucleos(t)ide medicine

Arm Title

Control

Arm Type

No Intervention

Arm Description

chronic hepatitis B patients with long term anti-virus therapy

Intervention Type

Drug

Intervention Name(s)

Vitamin D3

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in serum levels of 25-hydroxy vitamin D

Description

Change in serum levels of 25-hydroxyvitamin D at 6 months and 12 months compared to baseline

Time Frame

at baseline, and at 6 and 12 months

Secondary Outcome Measure Information:

Title

Change in serum creatinine

Description

Change in serum creatinine at 6 months and at 12 months compared to baseline

Time Frame

at baseline, and at 6 and 12 months

Title

Change in fibrosis score

Description

Change in fibrosis score at 6 months and at 12 months compared to baseline. The investigators use Fibroscan to get the score of fibrosis.

Time Frame

at baseline, and at 6 and 12 months

Title

Number of participants on Vitamin D treatment with adverse events

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yutian Chong, MD

ytchongkyzy@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yutian Chong, MD

Organizational Affiliation

Third Affiliated Hospital, Sun Yat-Sen University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

15470215

Citation

Liaw YF, Sung JJ, Chow WC, Farrell G, Lee CZ, Yuen H, Tanwandee T, Tao QM, Shue K, Keene ON, Dixon JS, Gray DF, Sabbat J; Cirrhosis Asian Lamivudine Multicentre Study Group. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med. 2004 Oct 7;351(15):1521-31. doi: 10.1056/NEJMoa033364.

Results Reference

result

PubMed Identifier

12865912

Citation

Dalhoff K, Dancey J, Astrup L, Skovsgaard T, Hamberg KJ, Lofts FJ, Rosmorduc O, Erlinger S, Bach Hansen J, Steward WP, Skov T, Burcharth F, Evans TR. A phase II study of the vitamin D analogue Seocalcitol in patients with inoperable hepatocellular carcinoma. Br J Cancer. 2003 Jul 21;89(2):252-7. doi: 10.1038/sj.bjc.6601104.

Results Reference

result

PubMed Identifier

18092326

Citation

Ding EL, Mehta S, Fawzi WW, Giovannucci EL. Interaction of estrogen therapy with calcium and vitamin D supplementation on colorectal cancer risk: reanalysis of Women's Health Initiative randomized trial. Int J Cancer. 2008 Apr 15;122(8):1690-4. doi: 10.1002/ijc.23311.

Results Reference

result

PubMed Identifier

20936945

Citation

Krishnan AV, Feldman D. Mechanisms of the anti-cancer and anti-inflammatory actions of vitamin D. Annu Rev Pharmacol Toxicol. 2011;51:311-36. doi: 10.1146/annurev-pharmtox-010510-100611.

Results Reference

result

PubMed Identifier

15749627

Citation

Woo TC, Choo R, Jamieson M, Chander S, Vieth R. Pilot study: potential role of vitamin D (Cholecalciferol) in patients with PSA relapse after definitive therapy. Nutr Cancer. 2005;51(1):32-6. doi: 10.1207/s15327914nc5101_5.

Results Reference

result

PubMed Identifier

19918922

Citation

Amir E, Simmons CE, Freedman OC, Dranitsaris G, Cole DE, Vieth R, Ooi WS, Clemons M. A phase 2 trial exploring the effects of high-dose (10,000 IU/day) vitamin D(3) in breast cancer patients with bone metastases. Cancer. 2010 Jan 15;116(2):284-91. doi: 10.1002/cncr.24749.

Results Reference

result

PubMed Identifier

25259922

Citation

Sherman MH, Yu RT, Engle DD, Ding N, Atkins AR, Tiriac H, Collisson EA, Connor F, Van Dyke T, Kozlov S, Martin P, Tseng TW, Dawson DW, Donahue TR, Masamune A, Shimosegawa T, Apte MV, Wilson JS, Ng B, Lau SL, Gunton JE, Wahl GM, Hunter T, Drebin JA, O'Dwyer PJ, Liddle C, Tuveson DA, Downes M, Evans RM. Vitamin D receptor-mediated stromal reprogramming suppresses pancreatitis and enhances pancreatic cancer therapy. Cell. 2014 Sep 25;159(1):80-93. doi: 10.1016/j.cell.2014.08.007.

Results Reference

result

Learn more about this trial

Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma

We'll reach out to this number within 24 hrs