MedTrace Logo

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

NCT00152815 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-07-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ontario HIV Treatment Network

    collaborator NETWORK

  • Johane Allard

    lead OTHER

Principal Investigators

  • Allard Johane, MD, FRCPC · University Health Network, Toronto General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152815 on ClinicalTrials.gov