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

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

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

Conditions
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Liver Disease, Short Bowel Syndrome

Intervention / Treatment
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* Drug: Lovaza (omega-3-acid ethyl ester)
* Dietary Supplement: Corn oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Days
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lovaza group<br>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)<br>* 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<br>* Other names: fish oil;|
| Placebo Comparator: Placebo group<br>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<br>* 1 gram per kilogram body weight per day, not exceeding 4 grams<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Time Frame |
| --- | --- | --- |
| 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). |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lovaza, oral fish oil, Omega-3-acid supplementation