Phase 4 N=10 Treatment

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

Chronic Hepatitis · Chronic Hepatitis C · Chronic Alcoholic Hepatitis

Bottom Line

View on ClinicalTrials.gov: NCT01413360 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2016

Primary outcome: Primary: The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks — 77.5; 105.5 IU/L

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: High dose vitamin C (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Seoul National University Hospital
Primary completion: Dec 2013

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	—

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.

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

View full record on ClinicalTrials.gov →

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.