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Treatment of Alcohol-Related Hepatitis With Arginine

This study has been withdrawn prior to enrollment.
(lack of enrollment)
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00200746
First received: September 12, 2005
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to test the effectiveness of the amino acid arginine in reducing liver injury in individuals with alcohol-related hepatitis.


Condition Intervention Phase
Alcoholic Hepatitis
 Drug: Arginine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arginine Treatment for Alcoholic Hepatitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Percent reduction in liver endotoxin production [ Time Frame: After nutritional intervention ] [ Designated as safety issue: No ]
  • change in Maddrey's discriminant function (DF) score [ Time Frame: After nutritional intervention ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Moderate Arginine
 Drug: Arginine
Amino Acid Arginine
Sham Comparator: 3
Polycose control arm
 Drug: Arginine
Amino Acid Arginine
Experimental: 1
High Arginine
 Drug: Arginine
Amino Acid Arginine

Detailed Description:

Arginine is a naturally occurring amino acid that is also available in pill form. Arginine pills have been shown to aid in liver detoxification and fat breakdown in the liver. Numerous studies have examined the effects of arginine on the liver. However, few have determined the optimal concentration of arginine that would best prevent injury to the liver This study will provide participants with three concentration levels of arginine to determine which is most effective in reducing liver injury in alcoholic hepatitis patients.

This study will last 31 days. Participants will be admitted to the General Clinical Research Center for 27 days. Participants will be randomly assigned to one of four groups. Participants in Groups 1, 2, and 3 will have 1%, 2%, or 6% arginine added to their diet in the form of gel capsules. Participants in Group 4 will receive placebo capsules. Participants will be given 24 capsules of different dietary supplements, including the arginine supplements, every day during their hospital stay.

Participants who are not able to ingest at least 18 capsules per day over 3 days or who are not able to eat the majority of their solid or liquid diet while hospitalized will have a naso-gastric soft feeding tube inserted for food and supplements to be administered. A liver biopsy will be performed on Days 3 and 26. The biopsies will involve insertion of a catheter in a neck vein and a small sample of liver tissue will be removed. On Days 2 and 25, participants will undergo blood and urine collection. Participants will also be infused with nonradioactive leucine to determine the levels of albumin, a protein that is reduced in diseased livers. If participants develop fluid in the abdomen (a condition known as ascites), a small sample of fluid will be extracted from the abdomen twice a day on Days 2, 17, and 25. On Day 31, participants will return to the research center for additional blood and urine collection.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of alcoholic hepatitis
  • Maddrey's DF score less than 33

Exclusion Criteria:

  • Hepatitis C or B virus infected
  • HIV infected
  • History of cancer
  • Hepatic encephalopathy (a condition in which liver failure affects the central nervous system)
  • Kidney failure
  • A Do Not Resuscitate order (a patient-directed order not to resuscitate in the event that resuscitation is necessary to prevent death)
  • Maddrey's DF score of 33 or greater after vitamin K administration during the study
  • Alcohol withdrawal at study entry
  • Active pneumonia at study entry
  • Allergy to iodine
  • Enrollment in any other clinical trials
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200746

Locations
United States, California
Harbor - University of California Los Angeles Medical Center
Torrance, California, United States, 90509
Sponsors and Collaborators
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: John A. Tayek, MD Los Angeles Biomedical Research Institute at Harbor - University of Los Angeles Medical Center
  More Information

No publications provided

Responsible Party: John Tayek, M.D., La BioMedical
ClinicalTrials.gov Identifier: NCT00200746     History of Changes
Other Study ID Numbers: R21 AT002394-01A1
Study First Received: September 12, 2005
Last Updated: March 11, 2013
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Hepatitis
Liver Diseases
Alcoholism
Arginine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 23, 2013