The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease

NCT ID: NCT01277237

Last Updated: 2014-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-08-31

Brief Summary

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There is preliminary evidence that Omega 3, a compound naturally found in fish oil, reduces the amount of fat stored in the liver and improves liver function. The purpose of this study is to see whether this observation is correct.

Detailed Description

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Conditions

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Non Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omacor

Group Type ACTIVE_COMPARATOR

Omacor

Intervention Type DRUG

Active comparator: omacor 4g/day

Lactose tablet

Group Type PLACEBO_COMPARATOR

lactose tablet

Intervention Type DRUG

placebo: lactose tablet 4g/day

Interventions

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Omacor

Active comparator: omacor 4g/day

Intervention Type DRUG

lactose tablet

placebo: lactose tablet 4g/day

Intervention Type DRUG

Other Intervention Names

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Omega-3 N-3 Fatty acids Placebo

Eligibility Criteria

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Inclusion Criteria

* a diagnosis of non-alcoholic fatty liver disease
* fatty infiltration on ultrasound
* abnormal serum liver function tests.

Exclusion Criteria

* any other identified cause of chronic liver disease
* the prescription of medication which would cause non-alcoholic fatty liver - disease (e.g. tamoxifen)
* already taking supplementary fish oil
* alcohol intake of \>20g/day for women, \>40g/ day for men
* known allergy to fish oil
* on anticoagulants (antiplatelets are permitted)
* severe heart failure (NYHA class IV)
* pregnancy/ lactation
* age under 18 years.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter C Hayes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Infirmary of Edinburgh

Locations

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Royal Infirmary of Edinburgh

Edinburgh, Lothian, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2008-008275-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Edin2008-008275-34

Identifier Type: -

Identifier Source: org_study_id

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