Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma

Prior treatment

• 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.

Other illness

• any evidence of autoimmune hepatitis, coinfection with hepatitis C or D virus or human immunodeficiency virus,

Lab values

• a serum alanine aminotransferase level more than 10 times the upper limit of normal,
• an elevated serum creatinine level,
• a diagnosis of hyperparathyroidism or other serious disturbance of calcium metabolism in the past 5 years,

Other

• evidence of hepatocellular carcinoma within 6 months after enrollment,
• any diagnosis of kidney stones,

• 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.