A Pilot Study of High-Dose, Intravenous Ascorbic Acid (Vitamin C) to Treat Hepatitis C

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this pilot study is to learn whether high doses of ascorbic acid (vitamin c), given intravenously to patients with chronic hepatitis due to infection with the genotype 1 version of the hepatitis C virus, are safe, well-tolerated and able to reduce the amount of virus circulating in the patients' blood.

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Detailed Description

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Hepatitis C virus (HCV) chronically infects 1% to 3% of the world's population, including about 3.9 million infected patients in the United States, with an estimated 36,000 new cases in the US each year. 70-85% of infected individuals develop a chronic infection complicated by chronic liver disease during the next 20 to 30 years, which is the tenth leading cause of death in the US. HCV is implicated in the development of hepato-cellular carcinoma. Chronic HCV hepatitis is the most frequent reason for liver transplantation. HCV genotype 1 is the most common genetic variant of HCV causing HCV hepatitis in the US. It responds less well to conventional anti-HCV treatment than the other HCV genotypes, so that 60% of genotype 1 patients fail conventional therapy due to the virus's resistance to treatment and/or due to toxic side effects of the therapy.

Extracellular levels of ascorbic acid (vitamin c) attainable only by high-dose, intravenous administration, are reported to have in vitro and in vivo anti-cancer and anti-viral effects in humans and animals. Ascorbic acid briefly generates extracellular hydrogen peroxide, an oxidative stress specifically toxic to cancer cells and cells infected with viruses, including HCV, but not to normal cells. High-dose, intravenous ascorbic acid has been given to large numbers of patients, particularly cancer patients, with anecdotal reports of good safety and occasional benefit. Given the foregoing, the investigators propose that there is sufficient rationale for a careful pilot study of the safety and anti-viral efficacy of infused ascorbic acid in HCV genotype 1 hepatitis.

Conditions

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Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ascorbic Acid (Vitamin C)

Group Type EXPERIMENTAL

ascorbic acid (vitamin C)

Intervention Type DIETARY_SUPPLEMENT

intravenous vitamin C, 25 to 100 grams, once or twice a week, for five months

Interventions

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ascorbic acid (vitamin C)

intravenous vitamin C, 25 to 100 grams, once or twice a week, for five months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vitamin C

Eligibility Criteria

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Inclusion Criteria

* hepatitis C, genotype 1
* failed treatment with interferon-alpha and ribavirin
* abstain from alcohol consumption for the duration of the study

Exclusion Criteria

* cirrhosis
* decompensated liver disease
* glucose6phosphate dehydrogenase deficiency
* AST or ALT more than 5 times upper limit of normal
* platelets less than 125,000
* diabetes mellitus
* alcohol and/or drug abuse within 1 year of screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No