Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
Recruitment status was Recruiting
The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated liver disease (PNALD) in children.
The study hypothesis is that Omegaven® can be safely provided to children who are dependent on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until the child can take adequate nutrition by mouth.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of a Fish Oil-Based Intravenous Lipid Emulsion (Omegaven®) in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury|
- Efficacy of parenteral administration of fish oil derived fat emulsion (Omegaven®) to reverse established parenteral nutrition associated liver disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]Normalization or trend toward normalization of direct bilirubin level
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Single Omegaven® Intervention Arm
10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Other Name: IV Fish Oil Based Lipid Emulsion
Rationale for Omegaven® Treatment
Unlike conventional intravenous fat emulsions, Omegaven® is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV lipid emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acid reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions(1,2). By administering Omegaven® in place of conventional phytosterol/soybean fat emulsions, the cholestasis may be reversed and patients will be able to be maintained on adequate PN until they are able to ingest adequate nutrition enterally.
- Chen W. Effects of fat emulsions with different fatty acid composition on plasma and hepatic lipids in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:24.
- Yeh S. Effects of fish oil and safflower oil emulsions on diet-induced hepatic steatosis in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:80.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01845116
|Contact: Ricardo A. Caicedo, MDfirstname.lastname@example.org|
|Contact: Michelle K. Chiu, MDemail@example.com|
|United States, North Carolina|
|Levine Children's Hospital at Carolinas HealthCare System||Recruiting|
|Charlotte, North Carolina, United States, 28232-2861|
|Contact: Ricardo A. Caicedo, MD 704-381-8880 firstname.lastname@example.org|
|Principal Investigator:||Ricardo A. Caicedo, MD||Levine Children's Hospital at Carolinas HealthCare System|