Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThird Affiliated Hospital, Sun Yat-Sen University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Vitamin D3
Treatment groups
1,500 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov