| Trial ID: | L0967 |
| Source ID: | EUCTR2008-008275-34-GB
|
| Associated Drug: |
Omega-3 Fatty Acids
|
| Title: |
The Effect of Omega-3 Fatty Acids on Non-Alcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic fatty liver disease <br>
MedDRA version: 9.1
Level: LLT
Classification code 10029530
Term: Non-alcoholic fatty liver
|
| Interventions: |
<br> Trade Name: Omacor<br> Pharmaceutical Form: Capsule, soft<br> CAS Number: 8000049754<br> Other descriptive name: OMEGA-3 TRIGLYCERIDES<br> Concentration unit: Ci/mg curie(s)/m
|
| Outcome Measures: |
Main Objective: To ascertain if omega-3 fatty acids improve the ultrasound appearance of the liver, particularly the liver fat content, in patients with non-alcoholic fatty liver disease.;<br> Secondary Objective: Secondary endpoints are ascertaining if:<br> - Omega-3 fatty acids improve serum liver function tests<br> - There is improvement in liver cell mitochondrial function with omega-3 supplementation.<br> - Supplementation with omega-3 fatty acids affect health-related quality of life in NAFLD patients.<br> ;Primary end point(s): The primary endpoint is improvement in grading on ultrasound assessment at six months. Liver brightness and posterior attenuation on ultrasound has previously been shown to correlate significantly with fat scores on liver biopsy.nan
|
| Sponsor/Collaborators: |
NHS Lothian
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Phase 3
|
| Enrollment: |
50
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
<br> Controlled: yes<br> Randomised: yes<br> Open: no<br> Single blind: no<br> Double blind: yes<br> Parallel group: no<br> Cross over: no<br>
|
| Start Date: |
06/07/2009
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
25 November 2019
|
| Locations: |
United Kingdom
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-008275-34
|
