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Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids

NCT00760513 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2019-10-25

Study results available
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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.

Conditions

  • Non-Alcoholic Fatty Liver Disease

Interventions

DRUG

OMACOR

4 grammes daily, oral capsule

DRUG

Placebo oral capsule

4 grammes daily, oral capsule (olive oil)

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Christopher D Byrne, MBBCh PhD · University of Southampton, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-01
Primary Completion
2013-11-01
Completion
2018-11-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00760513 on ClinicalTrials.gov