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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by University Health Network, Toronto.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Ontario HIV Treatment Network

Information provided by:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT00152815

First received: September 7, 2005

Last updated: January 22, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

January 22, 2010

Start Date ^ICMJE

October 2003

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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: Yes ]

Original Primary Outcome Measures ^ICMJE

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

Liver histology for steatosis and fibrosis staging [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: Yes ]
Liver immuno-histochemistry for adducts of MDA: a product of LP [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: Yes ]
Alpha-smooth muscle actin (alpha-SMA): a marker of hepatic stellate cell activation [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: Yes ]
Transforming growth factor (TGF-beta): a pro-fibrogenic cytokine involved in fibrogenesis [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: Yes ]
Liver lipid peroxides and TNP-alpha [ Time Frame: month 0, month 6 and month 12 ] [ Designated as safety issue: Yes ]
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 QUICKLY) will also be measured [ Time Frame: month 0, month 6 and month 12 ] [ Designated as safety issue: Yes ]
INF-alpha [ Time Frame: month 0, month 6 and month 12 ] [ Designated as safety issue: Yes ]
Lipid peroxide, vitamin E and C will aslo be measured in the plasma [ Time Frame: month 0, month 6 and month 12 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Study Arm (s)

Not Provided

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

July 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Gail Fernandes, BSc	416-340-4104	gfernand@uhnresearch.ca
Contact: Bianca M Arendt, PhD	416-340-4104	barendt@uhnresearch.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00152815

Other Study ID Numbers ^ICMJE

03-0297-B, ROGB139

Has Data Monitoring Committee

Not Provided

Responsible Party

Dr. Johane Allard, Toronto General Hospital

Study Sponsor ^ICMJE

University Health Network, Toronto

Collaborators ^ICMJE

Ontario HIV Treatment Network

Investigators ^ICMJE

Principal Investigator:

Allard Johane, MD, FRCPC

University Health Network, Toronto General Hospital

Information Provided By

University Health Network, Toronto

Verification Date

January 2010

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

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