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

This study has been terminated.
(Not enough eligible patients available)
Sponsor:
Collaborator:
Ontario HIV Treatment Network
Information provided by (Responsible Party):
Johane Allard, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00152815
First received: September 7, 2005
Last updated: July 17, 2013
Last verified: July 2013

September 7, 2005
July 17, 2013
October 2003
December 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the study
Complete list of historical versions of study NCT00152815 on ClinicalTrials.gov Archive Site
  • Liver histology for steatosis and fibrosis staging [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: No ]
  • Liver immuno-histochemistry for adducts of MDA: a product of LP [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: No ]
  • Alpha-smooth muscle actin (alpha-SMA): a marker of hepatic stellate cell activation [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: No ]
  • Transforming growth factor (TGF-beta): a pro-fibrogenic cytokine involved in fibrogenesis [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: No ]
  • Liver lipid peroxides and TNP-alpha [ Time Frame: month 0, month 6 and month 12 ] [ Designated as safety issue: No ]
    For oxidative stress and inflammation in the liver
  • Liver steatosis and volume will be assessed by ultrasound [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: Yes ]
  • Liver enzymes and IR (HOMA and QUICKY) will also be measured [ Time Frame: month 0, month 6 and month 12 ] [ Designated as safety issue: Yes ]
  • Lipid peroxides, TNF-alpha, vitamin E and C in plasma [ Time Frame: month 0, month 6 and month 12 ] [ Designated as safety issue: No ]
    Parameters for oxidative stress and antioxidant capacity
  • liver histology for steatosis and fibrosis staging
  • liver immuno-histochemistry for adducts fo MDA
  • a product of LP
  • alpha-smooth muscle actin (alpha-SMA)
  • a marker of hepatic stellate cell activation
  • transforming growth factor (TGF-beta)
  • a profibrogenic cytokine involved in fibrogenesis
  • liver lipid peroxides and TNP-alpha
  • liver steatosis and volume will be assessed by ultrasound
  • liver enzymes and IR (HOMA and QUICKLY) will also be measured
  • INF-alpha
  • lipid peroxide, vitamin E and C will aslo be measured in the plasma
Not Provided
Not Provided
 
Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions
Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Fatty Liver
  • 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
Experimental: Vitamin E
alpha-tocoperol, capsules, 2 per day
Interventions:
  • Drug: antioxidant vitamin E
  • Behavioral: weight reduction and exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00152815
03-0297-B, ROGB139
No
Johane Allard, University Health Network, Toronto
Johane Allard
Ontario HIV Treatment Network
Principal Investigator: Allard Johane, MD, FRCPC University Health Network, Toronto General Hospital
University Health Network, Toronto
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP