Chronic Alcoholic Hepatitis, Chronic Hepatitis, Chronic Hepatitis C
Conditions
Brief 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.
Detailed description
The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.
Interventions
Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks | Baseline and 12 weeks | Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks | Baseline and 12 weeks | Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HD Vitamin C High dose vitamin C
High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | HD Vitamin C |
|---|---|
| Age, Continuous | 62 years |
| ALT | 65 IU/L |
| Etiology Alcohol | 3 participants |
| Etiology HCV | 7 participants |
| Region of Enrollment Korea, Republic of | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD Vitamin C | The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks | ALT baseline | 77.5 IU/L |
| HD Vitamin C | The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks | ALT 12 weeks | 105.5 IU/L |
Secondary
The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks
Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HD Vitamin C | The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks | IL-22 baseline | 3.66 pg/mL |
| HD Vitamin C | The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks | IL-22 after 12 weeks | 4.04 pg/mL |