Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Alcohol-Related Hepatitis With Arginine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00200746
Recruitment Status : Withdrawn (lack of enrollment)
First Posted : September 20, 2005
Last Update Posted : March 12, 2013
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date March 12, 2013
Study Start Date  ICMJE April 2006
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2008)
  • Percent reduction in liver endotoxin production [ Time Frame: After nutritional intervention ]
  • change in Maddrey's discriminant function (DF) score [ Time Frame: After nutritional intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 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)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Alcohol-Related Hepatitis With Arginine
Official Title  ICMJE Arginine Treatment for Alcoholic Hepatitis
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcoholic Hepatitis
Intervention  ICMJE Drug: Arginine
Amino Acid Arginine
Study Arms  ICMJE
  • Experimental: 2
    Moderate Arginine
    Intervention: Drug: Arginine
  • Sham Comparator: 3
    Polycose control arm
    Intervention: Drug: Arginine
  • Experimental: 1
    High Arginine
    Intervention: Drug: Arginine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 15, 2010)
0
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
60
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00200746
Other Study ID Numbers  ICMJE R21AT002394-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Tayek, M.D., La BioMedical
Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE Office of Dietary Supplements (ODS)
Investigators  ICMJE
Principal Investigator: John A. Tayek, MD Los Angeles Biomedical Research Institute at Harbor - University of Los Angeles Medical Center
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date March 2013

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