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Treatment of Alcohol-Related Hepatitis With Arginine

Primary Purpose

Alcoholic Hepatitis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Arginine
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Hepatitis focused on measuring Hepatitis, Liver Diseases, Alcoholism, Arginine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harbor - University of California Los Angeles Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Experimental

Arm Label

2

3

1

Arm Description

Moderate Arginine

Polycose control arm

High Arginine

Outcomes

Primary Outcome Measures

Percent reduction in liver endotoxin production
change in Maddrey's discriminant function (DF) score

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
March 11, 2013
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
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1. Study Identification

Unique Protocol Identification Number
NCT00200746
Brief Title
Treatment of Alcohol-Related Hepatitis With Arginine
Official Title
Arginine Treatment for Alcoholic Hepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Withdrawn
Why Stopped
lack of enrollment
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Hepatitis
Keywords
Hepatitis, Liver Diseases, Alcoholism, Arginine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
Moderate Arginine
Arm Title
3
Arm Type
Sham Comparator
Arm Description
Polycose control arm
Arm Title
1
Arm Type
Experimental
Arm Description
High Arginine
Intervention Type
Drug
Intervention Name(s)
Arginine
Intervention Description
Amino Acid Arginine
Primary Outcome Measure Information:
Title
Percent reduction in liver endotoxin production
Time Frame
After nutritional intervention
Title
change in Maddrey's discriminant function (DF) score
Time Frame
After nutritional intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A. Tayek, MD
Organizational Affiliation
Los Angeles Biomedical Research Institute at Harbor - University of Los Angeles Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harbor - University of California Los Angeles Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States

12. IPD Sharing Statement

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Treatment of Alcohol-Related Hepatitis With Arginine

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