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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01277237

Enrollment

Registered

2011-01-14

Start date

2010-09-30

Completion date

2012-08-31

Last updated

2014-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

Non alcoholic fatty liver disease

Brief summary

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.

Interventions

DRUGOmacor

Active comparator: omacor 4g/day

DRUGlactose tablet

placebo: lactose tablet 4g/day

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Liver appearance on ultrasound	6 months	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.

Secondary

Measure	Time frame	Description
Liver function tests	6 months	the effect of omega-3 fatty acids on serum liver function tests will be assessed following 6 months of treatment.
hepatocyte mitochondrial function	6 months	heptocyte mitochondrial function will be measured by breath testing following 6 months of omega-3 supplementation
Health-related Quality of Life	6 months	Health related quality of life scores will be compared with baseline following 6 months of omega-3 supplementation

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026