Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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.