Investigational Study of Oral Fish Oil in Treating Parenteral Nutrition Associated Liver Disease
NCT ID: NCT01191177
Last Updated: 2017-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2011-01-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lovaza group
Patients randomized to this group will receive Lovaza 1gram per kilogram of body weight, not exceeding 4grams a day
Lovaza (omega-3-acid ethyl ester)
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
Placebo group
Patients randomized to this group will receive corn oil supplement 1gram per kilogram of body weight, not exceeding 4grams per day
Corn oil
1 gram per kilogram body weight per day, not exceeding 4 grams
Interventions
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Lovaza (omega-3-acid ethyl ester)
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 oil
1 gram per kilogram body weight per day, not exceeding 4 grams
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
30 Days
21 Years
ALL
No
Sponsors
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Harvard University
OTHER
GlaxoSmithKline
INDUSTRY
Boston Children's Hospital
OTHER
Responsible Party
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Tom Jaksic
W. Hardy Hendren Professor of Surgery, Harvard Medical School
Principal Investigators
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Tom Jaksic, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hopsital Boston
Locations
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Children's Hospital Boston
Boston, Massachusetts, United States
Countries
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Other Identifiers
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09-02-0066
Identifier Type: -
Identifier Source: org_study_id
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