Treatment of Alcohol-Related Hepatitis With Arginine

This study has been withdrawn prior to enrollment.
(lack of enrollment)
Sponsor:
Collaborator:
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

September 12, 2005
March 11, 2013
April 2006
July 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Percent eeduction in Endotoxin Production (Baseline vs 24 days of Dietary Therapy)
  • change in Maddrey’s DF Score (Baseline vs 24 days of Dietary Therapy)
  • liver biopsy (Baseline versus 24 days of Dietary Therapy)
Complete list of historical versions of study NCT00200746 on ClinicalTrials.gov Archive Site
Not Provided
  • Albumin Synthesis by 13C-Leucine
  • albumin half-life by 125 I-albumin (Baseline) and 131 I-albumin (Day 17)
  • improvements in Mayo End-Stage Liver Disease (MELD; Sheth 2002) and Child’s Pugh Score
Not Provided
Not Provided
 
Treatment of Alcohol-Related Hepatitis With Arginine
Arginine Treatment for Alcoholic Hepatitis

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcoholic Hepatitis
Drug: Arginine
Amino Acid Arginine
  • Experimental: 2
    Moderate Arginine
    Intervention: Drug: Arginine
  • Sham Comparator: 3
    Polycose control arm
    Intervention: Drug: Arginine
  • Experimental: 1
    High Arginine
    Intervention: Drug: Arginine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00200746
R21 AT002394-01A1
Yes
John Tayek, M.D., La BioMedical
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Principal Investigator: John A. Tayek, MD Los Angeles Biomedical Research Institute at Harbor - University of Los Angeles Medical Center
National Center for Complementary and Alternative Medicine (NCCAM)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP