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

Phase 2WithdrawnNCT01191177

Boston Children's Hospital

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Liver Disease Short Bowel Syndrome

Interventions

Lovaza (omega-3-acid ethyl ester)DRUG

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 oilDIETARY_SUPPLEMENT

1 gram per kilogram body weight per day, not exceeding 4 grams

Eligibility

Sex: ALLMin age: 30 DaysMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital Boston

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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 Outcomes

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).

Data from ClinicalTrials.gov

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