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

June 20, 2017 updated by: Tom Jaksic, Boston Children's Hospital

An Initial Trial of Enteral Fish Oil Supplementation in the Treatment of Parenteral Nutrition-associated Liver Disease in Patients With Short Bowel Syndrome

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lovaza group
Patients randomized to this group will receive Lovaza 1gram per kilogram of body weight, not exceeding 4grams a day
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
Other Names:
  • fish oil
PLACEBO_COMPARATOR: Placebo group
Patients randomized to this group will receive corn oil supplement 1gram per kilogram of body weight, not exceeding 4grams per day
Dietary supplement: Corn oil
1 gram per kilogram body weight per day, not exceeding 4 grams

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Outcome Measure
Measure Description
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

GlaxoSmithKline
Harvard University

Investigators

  • Principal Investigator: Tom Jaksic, MD, PhD, Children's Hopsital Boston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ANTICIPATED)

January 1, 2012

Study Completion (ANTICIPATED)

January 1, 2012

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

August 27, 2010

First Posted (ESTIMATE)

August 30, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-02-0066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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