Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma

NCT ID: NCT02779465

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2026-12-31

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.

Conditions

Hepatitis B; Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vitamin D

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

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

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

Control

chronic hepatitis B patients with long term anti-virus therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Yutian Chong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yutian Chong, MD

Role: PRINCIPAL_INVESTIGATOR

Third Affiliated Hospital, Sun Yat-Sen University

Central Contacts

Yutian Chong, MD

Role: CONTACT

ytchongkyzy@126.com

References

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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.

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Other Identifiers

SYSU-CYT-VD5010

Identifier Type: -

Identifier Source: org_study_id