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

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ClinicalTrials.gov Identifier: NCT00152815
Recruitment Status : Terminated (Not enough eligible patients available)
First Posted : September 9, 2005
Last Update Posted : July 19, 2013
Ontario HIV Treatment Network
Information provided by (Responsible Party):
Johane Allard, University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
HIV Infections Fatty Liver Drug: antioxidant vitamin E Behavioral: weight reduction and exercise Phase 2

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Study Type : Interventional
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions
Study Start Date : October 2003
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: Vitamin E
alpha-tocoperol, capsules, 2 per day
Drug: antioxidant vitamin E
Vitamin E 800IU per day for 12 months

Behavioral: 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.
Other 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

Primary Outcome Measures :
  1. The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the study [ Time Frame: month 0 and month 12 ]

Secondary Outcome Measures :
  1. Liver histology for steatosis and fibrosis staging [ Time Frame: month 0 and month 12 ]
  2. Liver immuno-histochemistry for adducts of MDA: a product of LP [ Time Frame: month 0 and month 12 ]
  3. Alpha-smooth muscle actin (alpha-SMA): a marker of hepatic stellate cell activation [ Time Frame: month 0 and month 12 ]
  4. Transforming growth factor (TGF-beta): a pro-fibrogenic cytokine involved in fibrogenesis [ Time Frame: month 0 and month 12 ]
  5. Liver lipid peroxides and TNP-alpha [ Time Frame: month 0, month 6 and month 12 ]
    For oxidative stress and inflammation in the liver

  6. Liver steatosis and volume will be assessed by ultrasound [ Time Frame: month 0 and month 12 ]
  7. Liver enzymes and IR (HOMA and QUICKY) will also be measured [ Time Frame: month 0, month 6 and month 12 ]
  8. Lipid peroxides, TNF-alpha, vitamin E and C in plasma [ Time Frame: month 0, month 6 and month 12 ]
    Parameters for oxidative stress and antioxidant capacity

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152815

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Canada, Ontario
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Johane Allard
Ontario HIV Treatment Network
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Principal Investigator: Allard Johane, MD, FRCPC University Health Network, Toronto General Hospital
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Responsible Party: Johane Allard, Gastroenterologist, Professor of Medicine, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00152815    
Other Study ID Numbers: 03-0297-B
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: July 2013
Keywords provided by Johane Allard, University Health Network, Toronto:
non-alcoholic fatty liver disease
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Vitamin E
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents