Status:
TERMINATED
Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions
Lead Sponsor:
Johane Allard
Collaborating Sponsors:
Ontario HIV Treatment Network
Conditions:
HIV Infections
Fatty Liver
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effect of a one-year nutritional intervention with either betaine or vitamin E supplementation, or a weight reducing diet and exercise program on liver ste...
Eligibility Criteria
Inclusion
- Baseline liver biopsy with macrovesicular fatty degeneration with inflammation (lobular or portal), with or without Mallory bodies, hepatocyte damage, and/or fibrosis diagnostic of NAFLD
- Convincing evidence of negligible alcohol consumption (\< 20 grams of ethanol per day) obtained from a detailed history, confirmed by at least one close relative
- If hyperlipidemia or diabetes, stable drug regimen required for the 6 months prior to and during the study
- Willingness to maintain stable weight and normal exercise program for the duration of the study, if randomized to vitamin E or betaine
Exclusion
- Liver disease of other etiology diagnosed as per routine medical investigation (e.g., chronic viral hepatitis, auto-immune chronic hepatitis, primary biliary cirrhosis or genetic liver disease such as Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, or biliary obstruction)
- Complications of liver disease such as recurrent variceal bleeding, resistant ascites, spontaneous portosystemic encephalopathy, or bacterial peritonitis
- Concurrent medical illness contra-indicating a liver biopsy, history of unexplained bleeding, hemophilia or abnormal coagulation results as per routine laboratory work-up or other reason judged by the hepatologist to contra-indicate a percutaneous liver biopsy
- Medications known to precipitate steatohepatitis (corticosteroids, high dose estrogens, methotrexate, amiodarone, calcium channel blockers, spironolactone, sulfasalazine, naproxen, oxacillin or ampinovire) in the 6 months prior to entry
- Antioxidant vitamin supplementation, ursodeoxycholic acid, or any other experimental drug 6 months prior to study entry
- Pregnant or lactating
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00152815
Start Date
October 1 2003
End Date
December 1 2010
Last Update
July 19 2013
Active Locations (1)
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1
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4