Status:
COMPLETED
Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 increa...
Detailed Description
We will recruit people with NAFLD who have been diagnosed as part of their NHS care with having this condition. At present there is no treatment for this condition. Over time a proportion of people wi...
Eligibility Criteria
Inclusion
- 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 units / week for women \<50 units / week for men).
- Exclusion criteria:
- Decompensated acute or chronic liver disease, or harmful drinking (\> 35 u/week in women \> 50 u /week in men).
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2018
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00760513
Start Date
November 1 2009
End Date
November 29 2018
Last Update
October 25 2019
Active Locations (1)
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1
Southamption General Hospital
Southampton, Hants, United Kingdom, SO166YD