| Trial ID: | L0863 |
| Source ID: | SLCTR/2015/023
|
| Associated Drug: |
Vitamin E
|
| Title: |
A randomized controlled, double blinded, clinical trial investigating the effects of Vitamin E Delta-tocotrienol supplementation in Nonalcoholic fatty liver disease
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic fatty liver disease (NAFLD)
|
| Interventions: |
The interventional product is Delta-tocotrienol, a natural Vitamin E compound that is available in the market as a dietary supplement.<br><br>Consenting participants fulfilling the inclusion/exclusion criteria will be randomized into two arms of 34 partic
|
| Outcome Measures: |
1. 40% reduction in Fatty Liver index (FLI) score from the baseline value<br>2. 25% reduction in insulin resistance (IR) calculated by Homeostasis Model Assessment (HOMA)<br> [At baseline,12 weeks and 24 weeks (end of trial)]<br>1. 40% reduction in High-sensitivity C-reactive protein (hs-CRP), Malondialdehyde (MDA), Alanine transaminase (ALT) and Aspartate transaminase (AST) from the baseline values
<br>
<br>2. Grading of NAFLD on ultrasonography
<br> [At baseline,12 weeks and 24 weeks(end of trial)]<br>
|
| Sponsor/Collaborators: |
Armed Forces Institute of Pathology, Pakistan
|
| Gender: |
--
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
68 (34 per group)
|
| Study Type: |
Interventional
|
| Study Designs: |
Randomized controlled trial
|
| Start Date: |
03/10/2015
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
7 February 2022
|
| Locations: |
Pakistan
|
| URL: |
https://slctr.lk/trials/slctr-2015-023
|
