View Clinical Trial (Medical Research Study)

A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease - NCT00969332-90095(Clinical Trial 319354)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Los Angeles
State:  
CA
Zip Code: 90095
Conditions: Parenteral Nutrition Associated Cholestasis
Purpose: The purpose of the study is to investigate if intravenous fish oil, commercially available as Omegaven, safely and effectively reverses Parenteral Nutrition Associated Cholestasis in children.
Study summary: Infants dependent on parenteral nutrition for greater than 1 year who develop Parenteral Nutrition Associated Cholestasis will universally face mortality unless they receive a timely liver and/or small bowel transplant. Although transplant survival has improved in recent years, survival is not guaranteed, and transplant care remains costly. Alternative nutritional and pharmacological strategies are imperative to improve the clinical outcomes of infants with Intestinal Failure and Parenteral Nutrition Associated Cholestasis. In both animal and human studies, intravenous fish oil, a lipid emulsion rich in omega-3 fatty acids and lacking phytosterols, has been shown to ameliorate Parenteral Nutrition Associated Cholestasis and improve morbidity and mortality. The purpose of this pilot study is to investigate if Omegaven, a commercially available intravenous fish oil, at 1 gm/kg/d for no longer than 24 weeks, will safely reverse liver disease in 15 subjects with Parenteral Nutrition Associated Cholestasis. Study subjects will be compared to a historical cohort of children with Short Bowel Syndrome and Parenteral Nutrition Associated Cholestasis who have been receiving standard intravenous soybean oil for > 60 days.
Criteria: Inclusion Criteria: - Clinical evidence of Parenteral Nutrition Associated Cholestasis - Direct bilirubin greater or equal to 2 mg/dL on 2 consecutive measurements - Expected parenteral nutrition course greater than 30 days - Acquired or congenital gastrointestinal disease - > 2 weeks of age and < 12 months of age - > 60% calories from parenteral nutrition - Hospitalized at the time of enrollment and initiation of fish oil - Failed standard therapies to prevent progression of liver disease (Actigal, cyclic parenteral nutrition, avoidance of overfeeding, reduction/removal of copper from parenteral nutrition if elevated my laboratory analysis, advancement of enteral feeds) Exclusion Criteria: - Inborn errors of metabolism - Extracorporeal Membrane Oxygenation - Seafood, egg, or Omegaven allergy - Documented case of liver disease other than Parenteral Nutrition Associated Cholestasis - Active coagulopathic state (INR > 1.5) or hemorrhagic disorder - Anticoagulant therapy - Hemodynamically unstable or in shock - Comatose state - Stroke, pulmonary embolism, recent myocardial infarction - Diabetes - Fatal chromosomal disorder - Enrollment in any other clinical trial involving an investigational agent - Patient, parent, or legal guardians unable or unwilling to give consent - Patient expected to weaned from parenteral nutrition in 30 days - unable to tolerate necessary monitoring
Study is available at: University of California, Los Angeles
Los Angeles, CA 90095
United States

Primary Contact:
Kara L Calkins, MD
Email: KCalkins@mednet.ucla.edu
Phone: 310-794-9855
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.