A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease - NCT00969332-90095 (Clinical Trial 319354)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy319354.aspx
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| City: |
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Los Angeles |
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State:
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CA |
| Zip Code: |
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90095 |
| Conditions: |
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Parenteral Nutrition Associated Cholestasis |
| Purpose: |
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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.
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| Study summary: |
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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: |
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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 |
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| Study is available at: |
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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 |
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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.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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