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

Phase 1

Withdrawn

• Conditions: Liver Disease; Short Bowel Syndrome
• Interventions: Dietary Supplement: Corn oil; Drug: Lovaza (omega-3-acid ethyl ester)

• Registration Number: NCT01191177
• Lead Sponsor: Boston Children's Hospital

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 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 Timeline

• Study First Submitted: 2010-08-27
• Study First Submitted QC: 2010-08-27
• Study First Posted: 2010-08-30
• Study Start: 2011-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Corn oil	Patients randomized to this group will receive corn oil supplement 1gram per kilogram of body weight, not exceeding 4grams per day
Lovaza group	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States