Phase 4
N=103
Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids
Non-Alcoholic Fatty Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT00760513 ↗Enrolled (actual)
103
Serious AEs
11.7%
Results posted
Oct 2019
Primary outcome: Primary: Percentage of Liver Fat — -7.9; -4.6 percentage of liver fat — p=0.48
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- OMACOR (Drug); Placebo oral capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital Southampton NHS Foundation Trust
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Liver Fat |
-7.9; -4.6 | 0.48 |
| PRIMARY Liver Fibrosis Score |
0.3; 0.2 | 1.0 |
| PRIMARY NAFLD Fibrosis Score |
0.8; 0.8 | 0.9 |
Summary
Non alcoholic fatty liver disease (NAFLD) imposes a high and increasing burden on the NHS, yet there is presently no licensed treatment or validated approach to management. NAFLD predisposes to increased risk of type 2 diabetes, increased risk of cardiovascular disease and may progress to chronic irreversible liver disease.
In NAFLD patients, the investigators will test the hypothesis that treatment with long chain n-3 fatty acid supplementation for 18 months favourably influences bio-markers for NAFLD and risk factors for cardiovascular disease and type 2 diabetes.
Eligibility Criteria
Inclusion criteria
- Steatohepatitis diagnosed on normal clinical grounds including in most cases liver biopsy and assessed by Kleiner scoring system to assess severity, with no known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B & C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).
- Steatosis diagnosed by ultrasound, CT or magnetic resonance imaging who also have either diabetes and/or features of the metabolic syndrome, without evidence of known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B & C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).
Liver biopsy or liver scan will be within 3 years of recruitment to the study. Age: men & women >18 years. Alcohol consumption 35 u/week in women > 50 u /week in men).
Data sourced from ClinicalTrials.gov (NCT00760513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.