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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
Sponsor:
Collaborator:
Ontario HIV Treatment Network
Information provided by (Responsible Party):
Johane Allard, University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 9, 2005
Last Update Posted Date July 19, 2013
Study Start Date  ICMJE October 2003
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the study
Change History Complete list of historical versions of study NCT00152815 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
  • Liver histology for steatosis and fibrosis staging [ Time Frame: month 0 and month 12 ]
  • Liver immuno-histochemistry for adducts of MDA: a product of LP [ Time Frame: month 0 and month 12 ]
  • Alpha-smooth muscle actin (alpha-SMA): a marker of hepatic stellate cell activation [ Time Frame: month 0 and month 12 ]
  • Transforming growth factor (TGF-beta): a pro-fibrogenic cytokine involved in fibrogenesis [ Time Frame: month 0 and month 12 ]
  • Liver lipid peroxides and TNP-alpha [ Time Frame: month 0, month 6 and month 12 ]
    For oxidative stress and inflammation in the liver
  • Liver steatosis and volume will be assessed by ultrasound [ Time Frame: month 0 and month 12 ]
  • Liver enzymes and IR (HOMA and QUICKY) will also be measured [ Time Frame: month 0, month 6 and month 12 ]
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions
Official Title  ICMJE Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Fatty Liver
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Vitamin E
alpha-tocoperol, capsules, 2 per day
Interventions:
  • Drug: antioxidant vitamin E
  • Behavioral: weight reduction and exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 17, 2013)
30
Original Enrollment  ICMJE
 (submitted: September 7, 2005)
90
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00152815
Other Study ID Numbers  ICMJE 03-0297-B
ROGB139
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johane Allard, University Health Network, Toronto
Study Sponsor  ICMJE Johane Allard
Collaborators  ICMJE Ontario HIV Treatment Network
Investigators  ICMJE
Principal Investigator: Allard Johane, MD, FRCPC University Health Network, Toronto General Hospital
PRS Account University Health Network, Toronto
Verification Date July 2013

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