The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients

Chronic Hepatitis C Clinical Trial

Official title:

Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01413360
• Other study ID #: VitC
• Status: Recruiting
• Phase: Phase 4
• First received: August 9, 2011
• Last updated: November 26, 2014
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: Seoul National University Hospital
• Contact: Jung-Hwan Yoon, M.D, Ph.D
• Phone: +82-2072-2228
• Email: yoonjh[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.

Description:

The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Chronic hepatitis C patients

• positive anti-HCV antibody more than 6 months

• serum alanine aminotransferase 40 - 80 IU/L for more than 6 months

• not indicated for antiviral therapy with interferon and ribavirin

2. Chronic alcoholic hepatitis

• significant alcohol drinking history and no other cause of chronic hepatitis

• serum alanine aminotransferase 40 - 80 IU/L for more than 6 months

Exclusion Criteria:

• Chronic hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, hemochromatosis, other chronic hepatitis except chronic hepatitis C or alcoholic hepatitis

• decompensated liver cirrhosis

• platelet < 50,000/uL or white blood cell < 1,500/uL

• need and willing for antiviral therapy

• significant renal dysfunction (GFR < 30 mL/min/kg) or history of renal stone

• hepatotonic drug (i.e. silymarin, garlic oil, aronamin gold) usage within 2 weeks

• pregnancy, lactating woman

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Alcoholic Hepatitis
• Chronic Hepatitis
• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C, Chronic
• Hepatitis, Alcoholic
• Hepatitis, Chronic

Intervention

Drug:
• High dose vitamin C
Vitamin C, 3g per day (tid), with meal, per oral with water 100mL

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of serum alanine aminotransferase level	Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration - Baseline serum ALT level	after 12 weeks	Yes
Secondary	The change of serum interleukin 22 level	Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration - Baseline IL-22 level	after 12 weeks	Yes