Phase 4
Completed N=10
The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients
Chronic Hepatitis · Chronic Hepatitis C · Chronic Alcoholic Hepatitis
Source: ClinicalTrials.gov NCT01413360 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks — 77.5; 105.5 IU/L
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks |
77.5; 105.5 | — |
| SECONDARY The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks |
3.66; 4.04 | — |
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01413360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.