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Hepatitis BPhase 4VDHCCNCT02779465

Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma

A Phase 4 study testing Vitamin D3 in people with Hepatitis B and Carcinoma, Hepatocellular, run by Third Affiliated Hospital, Sun Yat-Sen University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis B, Carcinoma, Hepatocellular
What is being tested?
Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
No sites listed yet
Study dates
Jun 2016to Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 9Show fewer
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yutian Chong, MD contact

ytchongkyzy@126.com

About this study

Official title: 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.

Read the 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.

Being tested
Vitamin D3
Keywords
vitamin D treatment, chronic hepatitis B
Medical subject headings
Hepatitis B, Carcinoma, Hepatocellular, Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3Drug

    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

Study groups in NCT02779465
Study groupRoleWhat they receive
Vitamin DExperimentalDrug: Vitamin D3 800 IU daily besides the anti-virus treatment with nucleos(t)ide medicine
Receives: Drug: Vitamin D3
ControlNo interventionchronic hepatitis B patients with long term anti-virus therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at baseline, and at 6 and 12 months

Secondary outcomes (3)

  1. Change in serum creatinine

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

    Measured: at baseline, and at 6 and 12 months

  2. 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.

    Measured: at baseline, and at 6 and 12 months

  3. Number of participants on Vitamin D treatment with adverse events

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2016 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02779465
Sponsor's protocol ID
SYSU-CYT-VD5010
Acronym
VDHCC
Status last verified
May 2016
First submitted
13 May 2016
Last updated
20 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 15470215

  • 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.

    PubMed 12865912

  • 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.

    PubMed 18092326

  • 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.

    PubMed 20936945

  • 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.

    PubMed 15749627

  • 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.

    PubMed 19918922

  • 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.

    PubMed 25259922

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin D3 in people with Hepatitis B and Carcinoma, Hepatocellular, run by Third Affiliated Hospital, Sun Yat-Sen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yutian Chong, MD (ytchongkyzy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum levels of 25-hydroxy vitamin D (time frame: at baseline, and at 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02779465, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.

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