Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200746
Status:
WITHDRAWN
Last Update Posted:
2013-03-12
First Post:
2005-09-12
Brief Title:
Treatment of Alcohol-Related Hepatitis With Arginine
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Arginine Treatment for Alcoholic Hepatitis
Status:
WITHDRAWN
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None