Non Alcoholic Fatty Liver DiseasePhase 3NCT01277237
The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease
A Phase 3 study testing Omacor and lactose tablet in people with Non Alcoholic Fatty Liver Disease, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease
- What is being tested?
- Omacor and lactose tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of non-alcoholic fatty liver disease
- fatty infiltration on ultrasound
- abnormal serum liver function tests.
Who cannot join
- 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)
Show all 9Show fewer
- severe heart failure (NYHA class IV)
- pregnancy/ lactation
- age under 18 years.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH164SA
About this study
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
- Being tested
- Omacor, lactose tablet
- Keywords
- Non alcoholic fatty liver disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmacorDrug
Also called Omega-3, N-3 Fatty acids
Active comparator: omacor 4g/day
lactose tabletDrug
Also called Placebo
placebo: lactose tablet 4g/day
| Study group | Role | What they receive |
|---|---|---|
| Omacor | Active comparator | Not described Receives: Drug: Omacor |
| Lactose tablet | Placebo comparator | Not described Receives: Drug: lactose tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Liver function tests
the effect of omega-3 fatty acids on serum liver function tests will be assessed following 6 months of treatment.
Measured: 6 months
hepatocyte mitochondrial function
heptocyte mitochondrial function will be measured by breath testing following 6 months of omega-3 supplementation
Measured: 6 months
Health-related Quality of Life
Health related quality of life scores will be compared with baseline following 6 months of omega-3 supplementation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Peter C Hayes, MD PhD, Principal investigator, Royal Infirmary of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277237
- Sponsor's protocol ID
- Edin2008-008275-34
- Other IDs
- 2008-008275-34, 2008
- Status last verified
- Dec 2010
- First submitted
- 13 Jan 2011
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT01277237
- Acronym / sponsor ID
- Edin2008-008275-34
- Conditions
- Non Alcoholic Fatty Liver Disease
- Keywords
- Non alcoholic fatty liver disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omacor | Active comparator | Drug: Omacor |
| Lactose tablet | Placebo comparator | Drug: lactose tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a diagnosis of non-alcoholic fatty liver disease
- fatty infiltration on ultrasound
- abnormal serum liver function tests.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmacorAlso: Omega-3, N-3 Fatty acidsActive comparator: omacor 4g/day | Drug | Omacor |
| lactose tabletAlso: Placeboplacebo: lactose tablet 4g/day | Drug | Lactose tablet |
Primary outcome
Liver appearance on ultrasound
Time frame: 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.
3 secondary outcomes
Liver function tests
Time frame: 6 months
hepatocyte mitochondrial function
Time frame: 6 months
Health-related Quality of Life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter C Hayes, MD PhD principal investigator
Royal Infirmary of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omacor and lactose tablet in people with Non Alcoholic Fatty Liver Disease, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver appearance on ultrasound (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.