Investigational Study of Oral Fish Oil in Treating Parenteral Nutrition Associated Liver Disease

• Status: Withdrawn
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Collaborators: GlaxoSmithKline; Harvard University

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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