Status:
WITHDRAWN
Investigational Study of Oral Fish Oil in Treating Parenteral Nutrition Associated Liver Disease
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Harvard University
GlaxoSmithKline
Conditions:
Liver Disease
Short Bowel Syndrome
Eligibility:
All Genders
30-21 years
Phase:
PHASE1
PHASE2
Brief 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 b...
Detailed Description
This is designed as a randomized placebo controlled trial of oral fish oil (Lovaza) in normalizing parenteral nutrition associated liver disease.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01191177
Start Date
January 1 2011
End Date
January 1 2012
Last Update
June 22 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115