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

• Sponsor: University of Edinburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT01277237
• Collaborator: NHS Lothian (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Fatty Liver Disease	Drug: Omacor; Drug: lactose tablet	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Omacor	Drug: Omacor; Active comparator: omacor 4g/day; Other Names: Omega-3 N-3 Fatty acids
Placebo Comparator: Lactose tablet	Drug: lactose tablet; placebo: lactose tablet 4g/day; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. hepatocyte mitochondrial function [6 months]

   heptocyte mitochondrial function will be measured by breath testing following 6 months of omega-3 supplementation

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Infirmary of Edinburgh	Edinburgh	Lothian	United Kingdom	EH164SA

Sponsors and Collaborators

• University of Edinburgh
• NHS Lothian

Investigators

• Principal Investigator: Peter C Hayes, MD PhD, Royal Infirmary of Edinburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Edinburgh
• ClinicalTrials.gov Identifier: NCT01277237
• Other Study ID Numbers: Edin2008-008275-34; 2008-008275-34
• First Posted: Jan 14, 2011
• Last Update Posted: Jan 23, 2014
• Last Verified: Dec 1, 2010

• Keywords provided by University of Edinburgh: Non alcoholic fatty liver disease
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Jan 23, 2014