Liver DiseasePhase 1/2NCT01191177
Investigational Study of Oral Fish Oil in Treating Parenteral Nutrition Associated Liver Disease
A Phase 1/2 study testing Lovaza (omega-3-acid ethyl ester) and Corn oil in people with Liver Disease and Short Bowel Syndrome, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in normalizing liver function in patients who have parenteral nutrition associated liver disease. The investigators believe that patients who take oral fish oil will normalize liver function faster than those who do not Read more about this study
- Who is it for?
- Ages 30 days to 21 years
- Conditions the study is for
- Liver Disease, Short Bowel Syndrome
- What is being tested?
- Lovaza (omega-3-acid ethyl ester) and Corn oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2012
- Phase
- Phase 1/2
- 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 30 days to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- History of parenteral nutrition(PN)administration >4weeks
- PN associated liver disease from intestinal failure
- ability to take full enteral feed
- body weight equal or greater than 3kg
- elevated ALT level twice of that normal(ALT>84)at the time PN is weaned off
Who cannot join
- Hemodynamic instability
- renal failure
- suspected congenital obstruction of the hepatobiliary system
- diagnosis hepatitis A, B, or C
- diagnosis of alpha 1-antitrypsin deficiency
- diagnosis of cytomegalovirus infection
- diagnosis of HIV
- children in care
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: An Initial Trial of Enteral Fish Oil Supplementation in the Treatment of Parenteral Nutrition-associated Liver Disease in Patients With Short Bowel Syndrome
The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in normalizing liver function in patients who have parenteral nutrition associated liver disease. The investigators believe that patients who take oral fish oil will normalize liver function faster than those who do not
Read the detailed description
This is designed as a randomized placebo controlled trial of oral fish oil (Lovaza) in normalizing parenteral nutrition associated liver disease.
- Conditions
- Liver Disease, Short Bowel Syndrome
- Being tested
- Lovaza (omega-3-acid ethyl ester), Corn oil
- Keywords
- oral fish oil, Lovaza, Omega-3-acid supplementation
- Medical subject headings
- Liver Diseases, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovaza (omega-3-acid ethyl ester)Drug
Also called fish oil
supplied as 1gram transparent soft-gelatin capsules filled with yellow oil, dosage is 1gram per kilogram of body weight per day, not exceeding 4grams per day until normalization of liver function test
Corn oilDietary supplement
1 gram per kilogram body weight per day, not exceeding 4 grams
| Study group | Role | What they receive |
|---|---|---|
| Lovaza group | Experimental | Patients randomized to this group will receive Lovaza 1gram per kilogram of body weight, not exceeding 4grams a day Receives: Drug: Lovaza (omega-3-acid ethyl ester) |
| Placebo group | Placebo comparator | Patients randomized to this group will receive corn oil supplement 1gram per kilogram of body weight, not exceeding 4grams per day Receives: Dietary Supplement: Corn oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization of ALT
The primary aim is to examine the efficacy of Lovaza, when compared to placebo, on normalizing liver function, as measured primarily by amino alanine transferase (ALT). The investigators believe that patients in the Lovaza group will normalize ALT faster than in the placebo group.
Secondary outcomes (1)
Normalization other liver function tests and inflammatory status
The investigators believe that Lovaza will result in faster reduction of the serum levels of the following markers: total bilirubin, aspartate amino transferase (AST), alkaline phosphatase, gamma glutamyl transpeptidase (GGTP) \& C-reactive protein (CRP).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Why it stopped: no subjects recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, GlaxoSmithKline
- Responsible party
- Principal investigator, Tom Jaksic, Boston Children's Hospital
- Investigators
- Tom Jaksic, MD, PhD, Principal investigator, Children's Hopsital Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191177
- Sponsor's protocol ID
- 09-02-0066
- Status last verified
- Jun 2017
- First submitted
- 27 Aug 2010
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Initial Trial of Enteral Fish Oil Supplementation in the Treatment of Parenteral Nutrition-associated Liver Disease in Patients With Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01191177
- Acronym / sponsor ID
- 09-02-0066
- Conditions
- Liver Disease, Short Bowel Syndrome
- Keywords
- oral fish oil, Lovaza, Omega-3-acid supplementation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no subjects recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Harvard University, GlaxoSmithKline
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 30 Aug 2010 (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.
The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in normalizing liver function in patients who have parenteral nutrition associated liver disease. The investigators believe that patients who take oral fish oil will normalize liver function faster than those who do not
Detailed description
This is designed as a randomized placebo controlled trial of oral fish oil (Lovaza) in normalizing parenteral nutrition associated liver disease.
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 |
|---|---|---|
| Lovaza group | Experimental | Drug: Lovaza (omega-3-acid ethyl ester)Patients randomized to this group will receive Lovaza 1gram per kilogram of body weight, not exceeding 4grams a day |
| Placebo group | Placebo comparator | Dietary Supplement: Corn oilPatients randomized to this group will receive corn oil supplement 1gram per kilogram of body weight, not exceeding 4grams per day |
Who may qualify
- Ages
- 30 days to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- History of parenteral nutrition(PN)administration >4weeks
- PN associated liver disease from intestinal failure
- ability to take full enteral feed
- body weight equal or greater than 3kg
- elevated ALT level twice of that normal(ALT>84)at the time PN is weaned off
Key exclusion criteria (8 listed)
- Hemodynamic instability
- renal failure
- suspected congenital obstruction of the hepatobiliary system
- diagnosis hepatitis A, B, or C
- diagnosis of alpha 1-antitrypsin deficiency
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 |
|---|---|---|
| Lovaza (omega-3-acid ethyl ester)Also: fish oilsupplied as 1gram transparent soft-gelatin capsules filled with yellow oil, dosage is 1gram per kilogram of body weight per day, not exceeding 4grams per day until normalization of liver function test | Drug | Lovaza group |
| Corn oil1 gram per kilogram body weight per day, not exceeding 4 grams | Dietary supplement | Placebo group |
Primary outcome
Normalization of ALT
The primary aim is to examine the efficacy of Lovaza, when compared to placebo, on normalizing liver function, as measured primarily by amino alanine transferase (ALT). The investigators believe that patients in the Lovaza group will normalize ALT faster than in the placebo group.
1 secondary outcome
Normalization other liver function tests and inflammatory status
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Tom Jaksic, MD, PhD principal investigator
Children's Hopsital Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lovaza (omega-3-acid ethyl ester) and Corn oil in people with Liver Disease and Short Bowel Syndrome, run by Boston Children's Hospital 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 8 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: withdrawn, as of the sponsor's last update on 22 Jun 2017. 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 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Normalization of ALT. 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 22 Jun 2017.