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

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

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01191177

Enrollment

Registered

2010-08-30

Start date

2011-01-31

Completion date

2012-01-31

Last updated

2017-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease, Short Bowel Syndrome

Keywords

oral fish oil, Lovaza, Omega-3-acid supplementation

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.

Interventions

DIETARY_SUPPLEMENTCorn oil

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

DRUGLovaza (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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Days to 21 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	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

Measure	Time frame	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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026