A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease (FO)
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ClinicalTrials.gov Identifier: NCT00969332 |
Recruitment Status
:
Recruiting
First Posted
: September 1, 2009
Last Update Posted
: March 6, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cholestasis | Drug: Omegaven | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Omegaven and Parenteral Nutrition Associated Cholestasis |
Study Start Date : | August 2009 |
Estimated Primary Completion Date : | August 2019 |
Estimated Study Completion Date : | August 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Omegaven
0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.
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Drug: Omegaven
0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
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- Time to reversal of Parenteral Nutrition Associated Cholestasis [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]serial liver function tests
- death [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]expiration
- transplant [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]includes isolated liver or multi-visceral transplant including liver graft
- time to full enteral feeds [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]discontinuation of parenteral nutrition
- growth [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]Z-scores
- risk for bleeding [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]serial platelet counts and international ratios
- essential fatty acid deficiency [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]triene:tetrane ratio >0.2
- markers of inflammation, liver injury, and sterol, lipid and bile acid metabolism [ Time Frame: during intervention and post-intervention ]serum cytokines, phytosterols, and bile acids, erythrocyte fatty acid profiles, and microRNA profiles
- gut microbiome [ Time Frame: during intervention and post-intervention ]intestinal microbiome

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Ages Eligible for Study: | up to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 < 18 years of age
- > 60% calories from parenteral nutrition
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969332
United States, California | |
University of California, Los Angeles | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Kara L Calkins, MD 310-794-9855 KCalkins@mednet.ucla.edu | |
Contact: Robert Venick, MD (310) 206-6134 RVenick@mednet.ucla.edu | |
Principal Investigator: Kara L Calkins, MD | |
Sub-Investigator: Stephen B Shew, MD | |
Sub-Investigator: James Dunn, MD, PhD | |
Sub-Investigator: Robert Venick, MD |
Principal Investigator: | Kara L Calkins, MD | University of California, Los Angeles |
Responsible Party: | Kara L. Calkins, MD, Assistant Professor, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00969332 History of Changes |
Other Study ID Numbers: |
09-02-079-02 |
First Posted: | September 1, 2009 Key Record Dates |
Last Update Posted: | March 6, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Kara L. Calkins, MD, University of California, Los Angeles:
liver Parenteral Nutrition fish oil Omegaven children |
Additional relevant MeSH terms:
Cholestasis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |