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Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

This study is currently recruiting participants.
Verified September 2017 by Lynn M. Iwamoto, Kapiolani Medical Center For Women & Children
Sponsor:
ClinicalTrials.gov Identifier:
NCT01194063
First Posted: September 2, 2010
Last Update Posted: September 25, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lynn M. Iwamoto, Kapiolani Medical Center For Women & Children
  Purpose
Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.

Condition Intervention Phase
Cholestasis Drug: Omega-3 fish oil lipid emulsion Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Omegaven for Parenteral Nutrition Associated Liver Disease

Resource links provided by NLM:


Further study details as provided by Lynn M. Iwamoto, Kapiolani Medical Center For Women & Children:

Primary Outcome Measures:
  • improving cholestasis [ Time Frame: One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment ]
    decline in serum direct bilirubin levels below 2 cm on 2 serial measures


Secondary Outcome Measures:
  • improving liver function tests [ Time Frame: 1 year ]
    includes ALT, AST, GGT, and triglycerides


Estimated Enrollment: 10
Study Start Date: September 2010
Estimated Study Completion Date: August 2025
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omegaven
Administration of intravenous Omega-3 fish oil lipid emulsion 1 g/kg continuous infusion over 12-24 hrs
Drug: Omega-3 fish oil lipid emulsion
daily intravenous administration of Omegaven fish oil emulsion
Other Name: Omegaven

Detailed Description:
Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. Animal studies have shown that IV fat emulsions such as fish oil that are high in eicosapentaenic and docosahexaenoic acids reduce impairment of bile flow as seen in cholestasis caused by conventional fat emulsions. It is thought that by administering Omegaven™ in place of conventional phytosterol/soybean fat emulsions, cholestasis may be prevented or reversed, and patients will be able to be maintained on adequate PN for growth until they are able to ingest adequate nutrition enterally. Ongoing studies are addressing safety and efficacy of Omegaven™ in the pediatric population. In this trial, infants and children with parenteral nutrition associated liver disease will receive Omegaven™ as compassionate use to potentially prevent progression of disease. Safety and efficacy are monitored.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • direct bilirubin > 2 mg/dl x2 consecutive
  • parenteral nutrition dependent, expected to continue for at least another 30 days from the first day
  • patient must have utilized standard therapies to prevent the progression of liver disease

Exclusion Criteria:

  • other primary cause of liver disease not parenteral nutrition-associated
  • weight <3 kg
  • infant or child enrolled in other clinical trial involving an investigational agent
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01194063


Contacts
Contact: Lynn M Iwamoto, MD 808-983-8670 lynni@kapiolani.org
Contact: Charles Neal, MD PhD 808-983-8670 cneal@kapiolani.org

Locations
United States, Hawaii
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Principal Investigator: Lynn M Iwamoto, MD         
Sub-Investigator: Charles R Neal, MD PhD         
Sub-Investigator: Sidney Johnson, MD         
Sponsors and Collaborators
Kapiolani Medical Center For Women & Children
Investigators
Principal Investigator: Lynn M Iwamoto, MD Kapiolani Medical Center For Women & Children
  More Information

Publications:
Responsible Party: Lynn M. Iwamoto, MD, Associate Professor of Pediatrics, Kapiolani Medical Center For Women & Children
ClinicalTrials.gov Identifier: NCT01194063     History of Changes
Other Study ID Numbers: 107954
First Submitted: June 17, 2010
First Posted: September 2, 2010
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lynn M. Iwamoto, Kapiolani Medical Center For Women & Children:
short bowel syndrome
parenteral nutrition associated liver disease
pediatric

Additional relevant MeSH terms:
Liver Diseases
Cholestasis
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases


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