Treatment of Alcohol-Related Hepatitis With Arginine

National Institutes of Health (NIH)

Status and phase: Withdrawn; Phase 2

Conditions: Alcoholic Hepatitis

Treatments: Drug: Arginine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00200746

R21AT002394-01A1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 3 patient groups

2

Experimental group

Description:

Moderate Arginine

Treatment:

Drug: Arginine

3

Sham Comparator group

Description:

Polycose control arm

Treatment:

Drug: Arginine

1

Experimental group

Description:

High Arginine

Treatment:

Drug: Arginine