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

Non Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277237
• Other study ID #: Edin2008-008275-34
• Secondary ID: 2008-008275-34
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2011
• Last updated: January 22, 2014
• Start date: September 2010
• Est. completion date: August 2012

Study information

• Verified date: December 2010
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non Alcoholic Fatty Liver Disease

Intervention

Drug:
• Omacor
Active comparator: omacor 4g/day
• lactose tablet
placebo: lactose tablet 4g/day

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Lothian

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Liver function tests	the effect of omega-3 fatty acids on serum liver function tests will be assessed following 6 months of treatment.	6 months	No
Secondary	hepatocyte mitochondrial function	heptocyte mitochondrial function will be measured by breath testing following 6 months of omega-3 supplementation	6 months	No
Secondary	Health-related Quality of Life	Health related quality of life scores will be compared with baseline following 6 months of omega-3 supplementation	6 months	No