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Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma

ConditionsHepatitis BCarcinoma, Hepatocellular
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Vitamin D3

    Drug

    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

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: Vitamin DExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

Time frame
at baseline, and at 6 and 12 months

Secondary outcomes

1

Change in serum creatinine

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

Time frame
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.

Time frame
at baseline, and at 6 and 12 months
3

Number of participants on Vitamin D treatment with adverse events

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Third Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: