NCT01250743

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 18, 2011

Status Verified

November 1, 2010

Enrollment Period

2.9 years

First QC Date

November 29, 2010

Last Update Submit

February 17, 2011

Conditions

Hepatitis C

Keywords

genotype 1

Outcome Measures

Primary Outcomes (1)

  • number of participants with adverse events as a measure of safety and tolerability

    clinical and/or laboratory adverse events

    6 months

Secondary Outcomes (3)

  • anti-viral efficacy

    6 months

  • aspartate aminotransferase (AST or SGOT)

    6 months

  • alanine aminotransferase (ALT or SGPT)

    6 months

Study Arms (1)

Ascorbic Acid (Vitamin C)

EXPERIMENTAL
Dietary Supplement: ascorbic acid (vitamin C)

Interventions

ascorbic acid (vitamin C)DIETARY_SUPPLEMENT

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

Also known as: Vitamin C
Ascorbic Acid (Vitamin C)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center, Department of Integrative Medicine

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

  • Choi J, Lee KJ, Zheng Y, Yamaga AK, Lai MM, Ou JH. Reactive oxygen species suppress hepatitis C virus RNA replication in human hepatoma cells. Hepatology. 2004 Jan;39(1):81-9. doi: 10.1002/hep.20001.

    PMID: 14752826BACKGROUND

  • Chen Q, Espey MG, Krishna MC, Mitchell JB, Corpe CP, Buettner GR, Shacter E, Levine M. Pharmacologic ascorbic acid concentrations selectively kill cancer cells: action as a pro-drug to deliver hydrogen peroxide to tissues. Proc Natl Acad Sci U S A. 2005 Sep 20;102(38):13604-9. doi: 10.1073/pnas.0506390102. Epub 2005 Sep 12.

    PMID: 16157892BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Jeanne A Drisko, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

  • Michael A Catalano, MD

    Frontier Research Institute/Health Innovations

    STUDY DIRECTOR

  • Terry A Grossman, MD

    Frontier Research Institute/Health Innovations

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2010

First Posted

December 1, 2010

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

February 18, 2011

Record last verified: 2010-11

Locations

US(1)