Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions

NCT ID: NCT00152815

Last Updated: 2013-07-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2010-12-31

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 steatosis and steatohepatitis.

Conditions

HIV Infections; Fatty Liver

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin E

alpha-tocoperol, capsules, 2 per day

Group Type: EXPERIMENTAL

antioxidant vitamin E

Intervention Type: DRUG

Vitamin E 800IU per day for 12 months

weight reduction and exercise

Intervention Type: BEHAVIORAL

Patients will be asked to consume a self-selected, low fat, low-calorie diet of approximately 1200 kcal/d, which is consistent with American Heart Association guidelines for healthy weight reduction. Subjects will be provided with a videotape involving a structured 20 min aerobic exercise to be performed 3x/week.

Interventions

antioxidant vitamin E

Vitamin E 800IU per day for 12 months

Intervention Type: DRUG

weight reduction and exercise

Patients will be asked to consume a self-selected, low fat, low-calorie diet of approximately 1200 kcal/d, which is consistent with American Heart Association guidelines for healthy weight reduction. Subjects will be provided with a videotape involving a structured 20 min aerobic exercise to be performed 3x/week.

Intervention Type: BEHAVIORAL

Other Intervention Names

This arm was removed from the study protocol, as the enrollment was slow and; a high drop-out rate was observed in the weigh-loss arm

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario HIV Treatment Network

NETWORK

Sponsor Role: collaborator

Johane Allard

OTHER

Sponsor Role: lead

Responsible Party

Johane Allard

Gastroenterologist, Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Allard Johane, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto General Hospital

Locations

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

ROGB139

Identifier Type: -

Identifier Source: secondary_id

03-0297-B

Identifier Type: -

Identifier Source: org_study_id