Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2006-04-30
2009-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2
Moderate Arginine
Arginine
Amino Acid Arginine
3
Polycose control arm
Arginine
Amino Acid Arginine
1
High Arginine
Arginine
Amino Acid Arginine
Interventions
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Arginine
Amino Acid Arginine
Eligibility Criteria
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Inclusion Criteria
* Maddrey's DF score less than 33
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Office of Dietary Supplements (ODS)
NIH
National Center for Complementary and Integrative Health (NCCIH)
NIH
Responsible Party
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La BioMedical
Principal Investigators
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John A. Tayek, MD
Role: PRINCIPAL_INVESTIGATOR
Los Angeles Biomedical Research Institute at Harbor - University of Los Angeles Medical Center
Locations
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Harbor - University of California Los Angeles Medical Center
Torrance, California, United States
Countries
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Other Identifiers
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