Fish Oil for Patients With Liver Disease Due to Parenteral Nutrition

Summary

Patients who are not able to eat normally for a longer time require parenteral nutrition, i.e. they receive liquids and nutrients directly into their veins. This can have many long-term side effects, including liver problems. This study will examine whether a specific lipid emulsion containing fish oil can improve liver disease in patients on parenteral nutrition. The investigators will compare changes in bilirubin and liver enzymes after 3 months in 10 patients receiving standard lipid emulsion to 10 patients receiving standard lipids + a fish-oil containing emulsion. The investigators will also assess liver histology, the kind of fat, oxidative stress and gene expression in the liver at the beginning and after 6 months of fish-oil. The investigators also want to compare the baseline values from all 20 patients to 20 healthy controls. This will help to explain how fish oil may improve liver disease in patients on parenteral nutrition.

Conditions

• Total Parenteral Nutrition-induced Cholestasis

Interventions

DRUG

Soybean oil (Standard treatment)

1\. Standard treatment: Soybean oil based emulsion: 0.25 g/kg/TPN day

DRUG

Soybean oil + Fish oil

Intralipid+Omegaven: 0.25 g/kg/TPN Intralipid day+0.4 g/kg/TPN Omegaven day for 6 months

Sponsors & Collaborators

• ASPEN Rhoads Research Foundation

  collaborator INDUSTRY

• Fresenius Kabi

  collaborator INDUSTRY

• University of Alberta

  collaborator OTHER

• Foothills Medical Centre

  collaborator OTHER

• St. Boniface Hospital

  collaborator OTHER

• Hamilton Health Sciences Corporation

  collaborator OTHER

• St. Paul's Hospital, Canada

  collaborator OTHER

• Johane Allard

  lead OTHER

Principal Investigators

• Johane P Allard, MD,FRCPC · University Health Network, Toronto

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2015-08-31

Completion

2015-08-31

Countries

• Canada

Study Locations