Clinical trial · Interventional
Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma
Study of Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma in Patients With Chronic Hepatitis B
NCT02779465CI-TRIAL-00022323VDHCCnot yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatitis B | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin D3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin D
- description
- Drug: Vitamin D3 800 IU daily besides the anti-virus treatment with nucleos(t)ide medicine
- interventionNames
- Drug: Vitamin D3
- type
- NO_INTERVENTION
- label
- Control
- description
- chronic hepatitis B patients with long term anti-virus therapy
Primary outcomes (1)
- measure
- Change in serum levels of 25-hydroxy vitamin D
- timeFrame
- at baseline, and at 6 and 12 months
- description
- Change in serum levels of 25-hydroxyvitamin D at 6 months and 12 months compared to baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (7)
- RESULTLiaw 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
- RESULTDalhoff 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
- RESULTDing 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
- RESULTKrishnan 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
- RESULTWoo 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
- RESULTAmir 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
- RESULTSherman 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.