Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma

NCT02779465 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: SYSU-CYT-VD5010
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis B; Carcinoma, Hepatocellular

Keywords

vitamin D treatment; chronic hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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

  at baseline, and at 6 and 12 months

Secondary Outcomes (3)

• Change in serum creatinine

  at baseline, and at 6 and 12 months

• Change in fibrosis score

  at baseline, and at 6 and 12 months

• Number of participants on Vitamin D treatment with adverse events

  1 year

Study Arms (2)

Vitamin D

EXPERIMENTAL

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

Drug: Vitamin D3

Control

NO INTERVENTION

chronic hepatitis B patients with long term anti-virus therapy

Interventions

Vitamin D3 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

Vitamin D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Related Publications (7)

• 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.

  PMID: 15470215 RESULT

• 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.

  PMID: 12865912 RESULT

• 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.

  PMID: 18092326 RESULT

• 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.

  PMID: 20936945 RESULT

• 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.

  PMID: 15749627 RESULT

• 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.

  PMID: 19918922 RESULT

• 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.

  PMID: 25259922 RESULT

MeSH Terms

Conditions

Hepatitis B; Carcinoma, Hepatocellular; Hepatitis B, Chronic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Yutian Chong, MD

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yutian Chong, MD

CONTACT

ytchongkyzy@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 20, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 20, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share