Non-alcoholic SteatohepatitisPhase 2/3NCT00681408
Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
A Phase 2/3 study testing Omega 3 Fish Oil supplements in people with Non-alcoholic Steatohepatitis and Fatty Liver, run by University of Virginia at 1 site in United States.
Trial summary
Nonalcoholic steatohepatitis (NASH) occurs in 2-3% of the US population and carries a 15-20% chance of progression to cirrhosis. It is closely associated with obesity, hyperlipidemia and insulin resistance. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Non-alcoholic Steatohepatitis, Fatty Liver
- What is being tested?
- Omega 3 Fish Oil supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Aug 2010
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NASH with NAS (NASH Activity Score) of >4 evident on a biopsy performed within 6 months of enrollment.
- Age 21 years or older.
- BMI 25 or greater.
- Ability to provide informed consent.
Who cannot join
- Cirrhosis evident clinically or on biopsy.
- Secondary forms of NASH such as that seen with bariatric surgery or medication induced from such medications as methotrexate, amiodarone, tamoxifen, corticosteroids.
- Current or past history of diabetes or hyperlipidemia requiring specific drug therapy (see below).
- Current use of a weight loss medicine, such as a 'fat-burner' or similar agent
- Alcohol consumption > 30 g/day, currently or for more than 3 consecutive months within 5 years.
- Other liver disease (hepatitis C,B, Wilson's, autoimmune, ct-1-antitrypsin and hemochromatosis or HIV
Show all 10Show fewer
- Pregnancy or unwillingness to use an effective form of birth control for women of child bearing years.
- Renal insufficiency (creatinine > 2), symptomatic coronary, peripheral or neurovascular disease, symptomatic heart failure or advanced respiratory disease requiring oxygen therapy.
- Inability to provide informed consent.
- Any condition in the opinion of the primary investigator that would contraindicate the patient's participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia School of Medicine
Charlottesville, Virginia, 22908
About this study
Nonalcoholic steatohepatitis (NASH) occurs in 2-3% of the US population and carries a 15-20% chance of progression to cirrhosis. It is closely associated with obesity, hyperlipidemia and insulin resistance. Therapy usually includes recommendations to increase exercise and to begin weight reducing diets but these goals are variably achieved and their relative effects in conjunction with pharmacological intervention have not been well defined. Moreover, these lifestyle changes can confound results of treatment trials if not quantified through conditioning testing and measures of body fat. Polyunsaturated fatty acids, especially formulation rich in omega-3, are widely accepted and endorsed in the medical community for their beneficial effects on hyperlipidemia and coronary disease risk reduction. Recent data suggests that omega-3 fatty acids ameliorate hepatic steatosis in humans and in animal models of NASH by reducing hepatic fat content. We hypothesize that a one year course of omega-3 fatty acid (3gm/day) will produce improvement in NASH histological injury independent of changes in weight (BMI) or degree of conditioning measured by the lactate threshold. The effects of the supplement will be compared to a placebo group and controlled for these lifestyle changes.
- Conditions
- Non-alcoholic Steatohepatitis, Fatty Liver
- Being tested
- Omega 3 Fish Oil supplements, Placebo
- Keywords
- Steatohepatitis, NASH, NAFLD, omega 3 fatty acids, Exercise conditioning
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 Fish Oil supplementsDrug
Also called Fish Oil capsules
Subjects in this arm will receive 3 grams daily Omega 3 fish oil supplements
PlaceboDrug
Fish oil placebo pills
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 recipient arm | Active comparator | Not described Receives: Drug: Omega 3 Fish Oil supplements |
| Placebo | Placebo comparator | Placebo fish oil Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS).
Measured: approximately 12 months from enrollment
Secondary outcomes (4)
Measurement of anthropometric indices (weight, BMI, waist circumference)
Measured: 12 months
Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill)
Measured: 12 months
Hepatic fat content measured by magnetic resonance imaging
Measured: 12 months
Changes in fasting plasma lipids, red cell fatty acid content, changes in anti-hyperlipidemia requirements, insulin sensitivity, and markers of inflammation including tumor necrosis factor and C-reactive protein
Measured: 12 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMar 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Stephen Caldwell, MD, University of Virginia
- Investigators
- Stephen H Caldwell, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681408
- Sponsor's protocol ID
- 12442
- Other IDs
- R21AT002901, IRB # 12442, GCRC: SHC003, Grant # 5R21AT2901-2
- Status last verified
- May 2015
- First submitted
- 19 May 2008
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Argo CK, Patrie JT, Lackner C, Henry TD, de Lange EE, Weltman AL, Shah NL, Al-Osaimi AM, Pramoonjago P, Jayakumar S, Binder LP, Simmons-Egolf WD, Burks SG, Bao Y, Taylor AG, Rodriguez J, Caldwell SH. Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial. J Hepatol. 2015 Jan;62(1):190-7. doi: 10.1016/j.jhep.2014.08.036. Epub 2014 Sep 6.
PubMed 25195547
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT00681408
- Acronym / sponsor ID
- 12442
- Conditions
- Non-alcoholic Steatohepatitis, Fatty Liver
- Keywords
- Steatohepatitis, NASH, NAFLD, omega 3 fatty acids, Exercise conditioning
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Mar 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 May 2008 (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.
Nonalcoholic steatohepatitis (NASH) occurs in 2-3% of the US population and carries a 15-20% chance of progression to cirrhosis. It is closely associated with obesity, hyperlipidemia and insulin resistance. Therapy usually includes recommendations to increase exercise and to begin weight reducing diets but these goals are variably achieved and their relative effects in conjunction with pharmacological intervention have not been well defined. Moreover, these lifestyle changes can confound results of treatment trials if not quantified through conditioning testing and measures of body fat. Polyunsaturated fatty acids, especially formulation rich in omega-3, are widely accepted and endorsed in the medical community for their beneficial effects on hyperlipidemia and coronary disease risk reduction. Recent data suggests that omega-3 fatty acids ameliorate hepatic steatosis in humans and in animal models of NASH by reducing hepatic fat content. We hypothesize that a one year course of omega-3 fatty acid (3gm/day) will produce improvement in NASH histological injury independent of changes in weight (BMI) or degree of conditioning measured by the lactate threshold. The effects of the supplement will be compared to a placebo group and controlled for these lifestyle changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3 recipient arm | Active comparator | Drug: Omega 3 Fish Oil supplements |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo fish oil |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- NASH with NAS (NASH Activity Score) of >4 evident on a biopsy performed within 6 months of enrollment.
- Age 21 years or older.
- BMI 25 or greater.
- Ability to provide informed consent.
Key exclusion criteria (10 listed)
- Cirrhosis evident clinically or on biopsy.
- Secondary forms of NASH such as that seen with bariatric surgery or medication induced from such medications as methotrexate, amiodarone, tamoxifen, corticosteroids.
- Current or past history of diabetes or hyperlipidemia requiring specific drug therapy (see below).
- Current use of a weight loss medicine, such as a 'fat-burner' or similar agent
- Alcohol consumption > 30 g/day, currently or for more than 3 consecutive months within 5 years.
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 |
|---|---|---|
| Omega 3 Fish Oil supplementsAlso: Fish Oil capsulesSubjects in this arm will receive 3 grams daily Omega 3 fish oil supplements | Drug | Omega 3 recipient arm |
| PlaceboFish oil placebo pills | Drug | Placebo |
Primary outcome
The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS).
Time frame: approximately 12 months from enrollment
4 secondary outcomes
Measurement of anthropometric indices (weight, BMI, waist circumference)
Time frame: 12 months
Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill)
Time frame: 12 months
Hepatic fat content measured by magnetic resonance imaging
Time frame: 12 months
Changes in fasting plasma lipids, red cell fatty acid content, changes in anti-hyperlipidemia requirements, insulin sensitivity, and markers of inflammation including tumor necrosis factor and C-reactive protein
Time frame: 12 mos
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 29 May 2015.
- Derived from this study: PubMed 25195547Argo CK, Patrie JT, Lackner C, Henry TD, de Lange EE, Weltman AL, Shah NL, Al-Osaimi AM, Pramoonjago P, Jayakumar S, Binder LP, Simmons-Egolf WD, Burks SG, Bao Y, Taylor AG, Rodriguez J, Caldwell SH. Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial. J Hepatol. 2015 Jan;62(1):190-7. doi: 10.1016/j.jhep.2014.08.036. Epub 2014 Sep 6.
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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.
Stephen H Caldwell, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omega 3 Fish Oil supplements in people with Non-alcoholic Steatohepatitis and Fatty Liver, run by University of Virginia at 1 site in United States.
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 4 inclusion and 10 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 29 May 2015. 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 States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). (time frame: approximately 12 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00681408, which also lists 1 linked publication.
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 29 May 2015.