| Trial ID: | L0761 |
| Source ID: | NCT00152815
|
| Associated Drug: |
Vitamin E
|
| Title: |
Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
HIV Infections;Fatty Liver
|
| Interventions: |
Drug: antioxidant vitamin E;Behavioral: weight reduction and exercise
|
| Outcome Measures: |
The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the studyLiver histology for steatosis and fibrosis staging;Liver immuno-histochemistry for adducts of MDA: a product of LP;Alpha-smooth muscle actin (alpha-SMA): a marker of hepatic stellate cell activation;Transforming growth factor (TGF-beta): a pro-fibrogenic 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 QUICKY) will also be measured;Lipid peroxides, TNF-alpha, vitamin E and C in plasma
|
| Sponsor/Collaborators: |
Johane Allard
|
| Gender: |
All
|
| Age: |
18 Yearsnan
|
| Phases: |
Phase 2
|
| Enrollment: |
30
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
| Start Date: |
07/09/2005
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
19 February 2015
|
| Locations: |
Canada
|
| URL: |
http://clinicaltrials.gov/show/NCT00152815
|
