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

Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01191177
• Other study ID #: 09-02-0066
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: August 27, 2010
• Last updated: June 20, 2017
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: June 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Description:

This is designed as a randomized placebo controlled trial of oral fish oil (Lovaza) in normalizing parenteral nutrition associated liver disease.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases
• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• 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

Dietary Supplement:
• Corn oil
1 gram per kilogram body weight per day, not exceeding 4 grams

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children’s Hospital	GlaxoSmithKline, Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).