Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 68 of 517 for:    hepatitis b | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2016 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Yutian Chong, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT02779465
First received: May 13, 2016
Last updated: May 19, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Hepatitis B
Carcinoma, Hepatocellular
Drug: Vitamin D3
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Third Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • Change in serum levels of 25-hydroxy vitamin D [ Time Frame: at baseline, and at 6 and 12 months ] [ Designated as safety issue: No ]
    Change in serum levels of 25-hydroxyvitamin D at 6 months and 12 months compared to baseline


Secondary Outcome Measures:
  • Change in serum creatinine [ Time Frame: at baseline, and at 6 and 12 months ] [ Designated as safety issue: No ]
    Change in serum creatinine at 6 months and at 12 months compared to baseline

  • Change in fibrosis score [ Time Frame: at baseline, and at 6 and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: June 2016
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02779465

Contacts
Contact: Yutian Chong, MD ytchongkyzy@126.com

Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
Principal Investigator: Yutian Chong, MD Third Affiliated Hospital, Sun Yat-Sen University
  More Information

Publications:

Responsible Party: Yutian Chong, Professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02779465     History of Changes
Other Study ID Numbers: SYSU-CYT-VD5010 
Study First Received: May 13, 2016
Last Updated: May 19, 2016
Health Authority: China: Health and Family Planning Commission of Guangdong Province
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Third Affiliated Hospital, Sun Yat-Sen University:
vitamin D treatment
chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Carcinoma
Carcinoma, Hepatocellular
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hepadnaviridae Infections
DNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016