Non-alcoholic Fatty Liver DiseasePhase 1NCT00694746
Study of Fish Oil to Reduce ALT Levels in Adolescents
A Phase 1 study testing Omega-3-acid ethyl esters in people with Non-alcoholic Fatty Liver Disease and Fatty Liver, run by Boston University at 1 site in United States.
Trial summary
This trial will provide preliminary data to test the hypothesis that a six-month treatment period with fish oil for overweight adolescent with mild to moderate persistent elevation of ALT levels and presence of hepatic steatosis on CT-scan is safe and will result in decreased ALT. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Fatty Liver
- What is being tested?
- Omega-3-acid ethyl esters
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Mar 2014
- Phase
- Phase 1
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI (kg/m2) at or above the 95th percentile for age and gender
- Weight below 400 pounds (less than 182 kilograms)
- Persistent elevation of ALT (41-90 UI/L at study screening)
- Presence of hepatic steatosis on abdominal CT-scan
- Able to give informed consent/assent
Who cannot join
- Type 2 diabetes mellitus
- Prior drug treatment for diabetes, insulin insensitivity, or weight loss medications six months before screening
- Use of prescription strength glucocorticoids within three months before screening
- History of syndrome or medical disorder associated with significant obesity
- Participation in a weight loss program within six months of screening resulting in 5% or more weight loss
- History of weight loss surgery
Show all 15Show fewer
- Alcohol use more than twice weekly or more than 3 alcohol containing beverages within a 24-hour period in the past six months
- Known or suspected bleeding condition
- History of liver disease including prior liver biopsy with NASH type 2 or cirrhosis
- Former or present positive blood tests for Infectious hepatitis B or C, autoimmune hepatitis, Wilson disease, Alpha-1 anti-trypsin deficiency, Iron storage disease, or high TSH
- History of past or current pregnancy
- Use of illegal/illicit drugs
- Other conditions contraindicated or cause for caution in the use of fish oil
- Unable to comply with the protocol
- Any other serious disease determined by the study gastroenterologists and physician nutrition specialist as potential study risk for the patient
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Randomized Trial of Fish Oil Versus Placebo to Reduce ALT Levels in Overweight Adolescents
This trial will provide preliminary data to test the hypothesis that a six-month treatment period with fish oil for overweight adolescent with mild to moderate persistent elevation of ALT levels and presence of hepatic steatosis on CT-scan is safe and will result in decreased ALT.
Read the detailed description
Over the past two decades, pre-adult nonalcoholic fatty liver disease (NAFLD) has emerged from the relative obscurity to become the most common cause of liver disease in pediatric patients. Currently, over 17% of US children and adolescents have a BMI at or greater than the 95th percentile for age and gender and 20% of children in weight management programs are estimated to have NAFLD. Untreated NAFLD can lead to fibrosis and to established cirrhosis in children as young as 10. Fish oils are a rich source of omega-3-acid ethyl esters or n-3 long-chain polyunsaturated fatty acids, and increasing evidence suggest they may safely improve hepatic steatosis. Given the prevalence of obesity, of NAFLD, and the severe, progressive nature of this condition, effective treatment strategies are urgently needed. We plan to gather preliminary data on the efficacy and safety of fish oil supplements in reducing persistent elevation of ALT levels and hepatic steatosis on abdominal CT-scan among urban youth (BMI>=95th percentile). This preliminary data will provide the necessary information to calculate the sample size for a phase 2 trial.
- Conditions
- Non-alcoholic Fatty Liver Disease, Fatty Liver
- Being tested
- Omega-3-acid ethyl esters, Placebo
- Keywords
- ALT, Non-Alcoholic Fatty Liver Disease, Adolescents, Overweight, Treatment
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3-acid ethyl estersDrug
Also called Omacor, Lovaza
Participants will receive 2 capsules of 1 gram of fish oil with meals twice a day for a period of six months (including a ramp up period of three weeks)
PlaceboDrug
Also called corn oil
Participants will receive 2 capsules of 1 gram of placebo with meals twice a day for a period of six months (including a ramp up period of three weeks)
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Experimental | Omega-3-acid ethyl esters in the form of fish oil capsules with ram up from 1g to 4 g/day (capsules 1g) Receives: Drug: Omega-3-acid ethyl esters |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy parameters: Characterize the reduction in ALT levels.
Measured: 3 and 6 months from baseline
Safety/compliance parameters: Describe the safety blood tests results, review of systems, and physical examination at baseline, mid point, and end of treatment, as well as identify adverse events and compliance parameters at study contacts.
Measured: From baseline to end of treatment
Secondary outcomes (1)
Improvement in waist circumference, insulin and lipid indices, and other metabolic parameters.
Measured: 3 and 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Study closed for slow recruitment
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 Boston UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Carine Lenders, Boston University
- Investigators
- Carine M Lenders, MD, MS, ScD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694746
- Sponsor's protocol ID
- IIT40
- Status last verified
- Jan 2016
- First submitted
- 6 Jun 2008
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Design with difficult enrollement
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Fish Oil Versus Placebo to Reduce ALT Levels in Overweight Adolescents
- ClinicalTrials.gov ID
- NCT00694746
- Acronym / sponsor ID
- IIT40
- Conditions
- Non-alcoholic Fatty Liver Disease, Fatty Liver
- Keywords
- ALT, Non-Alcoholic Fatty Liver Disease, Adolescents, Overweight, Treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed for slow recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Jun 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.
This trial will provide preliminary data to test the hypothesis that a six-month treatment period with fish oil for overweight adolescent with mild to moderate persistent elevation of ALT levels and presence of hepatic steatosis on CT-scan is safe and will result in decreased ALT.
Detailed description
Over the past two decades, pre-adult nonalcoholic fatty liver disease (NAFLD) has emerged from the relative obscurity to become the most common cause of liver disease in pediatric patients. Currently, over 17% of US children and adolescents have a BMI at or greater than the 95th percentile for age and gender and 20% of children in weight management programs are estimated to have NAFLD. Untreated NAFLD can lead to fibrosis and to established cirrhosis in children as young as 10. Fish oils are a rich source of omega-3-acid ethyl esters or n-3 long-chain polyunsaturated fatty acids, and increasing evidence suggest they may safely improve hepatic steatosis. Given the prevalence of obesity, of NAFLD, and the severe, progressive nature of this condition, effective treatment strategies are urgently needed. We plan to gather preliminary data on the efficacy and safety of fish oil supplements in reducing persistent elevation of ALT levels and hepatic steatosis on abdominal CT-scan among urban youth (BMI>=95th percentile). This preliminary data will provide the necessary information to calculate the sample size for a phase 2 trial.
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 |
|---|---|---|
| Fish oil | Experimental | Drug: Omega-3-acid ethyl estersOmega-3-acid ethyl esters in the form of fish oil capsules with ram up from 1g to 4 g/day (capsules 1g) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- BMI (kg/m2) at or above the 95th percentile for age and gender
- Weight below 400 pounds (less than 182 kilograms)
- Persistent elevation of ALT (41-90 UI/L at study screening)
- Presence of hepatic steatosis on abdominal CT-scan
- Able to give informed consent/assent
Key exclusion criteria (15 listed)
- Type 2 diabetes mellitus
- Prior drug treatment for diabetes, insulin insensitivity, or weight loss medications six months before screening
- Use of prescription strength glucocorticoids within three months before screening
- History of syndrome or medical disorder associated with significant obesity
- Participation in a weight loss program within six months of screening resulting in 5% or more weight loss
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-acid ethyl estersAlso: Omacor, LovazaParticipants will receive 2 capsules of 1 gram of fish oil with meals twice a day for a period of six months (including a ramp up period of three weeks) | Drug | Fish oil |
| PlaceboAlso: corn oilParticipants will receive 2 capsules of 1 gram of placebo with meals twice a day for a period of six months (including a ramp up period of three weeks) | Drug | Placebo |
Primary outcome
Efficacy parameters: Characterize the reduction in ALT levels.
Time frame: 3 and 6 months from baseline
Safety/compliance parameters: Describe the safety blood tests results, review of systems, and physical examination at baseline, mid point, and end of treatment, as well as identify adverse events and compliance parameters at study contacts.
Time frame: From baseline to end of treatment
1 secondary outcome
Improvement in waist circumference, insulin and lipid indices, and other metabolic parameters.
Time frame: 3 and 6 months from baseline
Results and safety
The study was stopped early (reason given: Study closed for slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Individual participant dataSharing planned: No. Design with difficult enrollement
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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.
Carine M Lenders, MD, MS, ScD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omega-3-acid ethyl esters in people with Non-alcoholic Fatty Liver Disease and Fatty Liver, run by Boston University 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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 29 Jan 2016. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Study closed for slow recruitment). Results are not available in the source record.
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?
Efficacy parameters: Characterize the reduction in ALT levels. (time frame: 3 and 6 months from baseline). The study lists 2 primary outcomes in all. 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 29 Jan 2016.