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

NCT01277237 | Completed Phase 3

• 2 other identifiers: Edin2008-008275-342008-008275-34
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

Non alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (1)

• Liver appearance on ultrasound

  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.

  6 months

Secondary Outcomes (3)

• Liver function tests

  6 months

• hepatocyte mitochondrial function

  6 months

• Health-related Quality of Life

  6 months

Study Arms (2)

Omacor

ACTIVE COMPARATOR

Drug: Omacor

Lactose tablet

PLACEBO COMPARATOR

Drug: lactose tablet

Interventions

Omacor DRUG

Active comparator: omacor 4g/day

Also known as: Omega-3, N-3 Fatty acids

Omacor

lactose tablet DRUG

placebo: lactose tablet 4g/day

Also known as: Placebo

Lactose tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH164SA, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Omacor; Docosahexaenoic Acids; Fatty Acids, Omega-3; Lactose

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Peter C Hayes, MD PhD

  Royal Infirmary of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 14, 2011
• Study Start: September 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 23, 2014

Record last verified: 2010-12

Locations

GB (1)