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

University of Edinburgh

Status and phase: Completed; Phase 3

Conditions: Non Alcoholic Fatty Liver Disease

Treatments: Drug: lactose tablet; Drug: Omacor

Study type: Interventional

Funder types: Other

Identifiers

NCT01277237

Edin2008-008275-34

2008-008275-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

50 participants in 2 patient groups, including a placebo group

Omacor

Active Comparator group

Treatment:

Drug: Omacor

Lactose tablet

Placebo Comparator group

Treatment:

Drug: lactose tablet