A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease (FO)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00969332 |
Recruitment Status :
Terminated
(study intervention was approved by the FDA)
First Posted : September 1, 2009
Results First Posted : February 12, 2020
Last Update Posted : February 26, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cholestasis | Drug: Omegaven | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Omegaven and Parenteral Nutrition Associated Cholestasis |
Actual Study Start Date : | August 2009 |
Actual Primary Completion Date : | January 12, 2019 |
Actual Study Completion Date : | February 12, 2019 |
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 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday |
- Time to Reversal of Parenteral Nutrition Associated Cholestasis [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]weeks
- Death [ Time Frame: 24 weeks, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]expiration
- Number of Participants Who Underwent a Transplant [ Time Frame: 24 weeks, death, 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 Z-scores [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]
Weight Z-scores at the end of the study. Formula used: (weight at end of study-average weight of reference population)/standard deviation of weight of reference population.
The Z-score indicates the number of standard deviations away from the mean. A weight Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A weight Z-score </= -2 indicates an underweight or malnourished status, while a weight Z-score >/= 2 indicates an overweight or obese status.
- Platelet Counts at the End of the Study - Risk of Bleeding [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]platelet counts at the end of the study
- Number of Participants With Essential Fatty Acid Deficiency [ Time Frame: 24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first) ]triene:tetraene ratio less than 0.2
- Markers of Inflammation [ Time Frame: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first) ]Serum Cytokines - interleukin-8
- Markers of Sterol Metabolism [ Time Frame: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first) ]Serum Phytosterols - stigmasterol
- Markers of Bile Acid Metabolism [ Time Frame: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first) ]Serum Bile acids - total chenodeoxycholic acid
- Markers of Fatty Acid Metabolism [ Time Frame: 24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first) ]Erythrocyte fatty acid - Docosahexaenoic Acid

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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
- 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 be weaned from parenteral nutrition in 30 days
- unable to tolerate necessary monitoring
- Patient requiring aspirin or toradel or motrin
- Patient requiring dialysis

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 | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Kara L Calkins, MD | University of California, Los Angeles |
Documents provided by Kara L. Calkins, MD, University of California, Los Angeles:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kara L. Calkins, MD, Assistant Professor, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00969332 |
Other Study ID Numbers: |
09-02-079-02 |
First Posted: | September 1, 2009 Key Record Dates |
Results First Posted: | February 12, 2020 |
Last Update Posted: | February 26, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
liver parenteral nutrition fish oil omegaven children |
Cholestasis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |