Clinical trial NCT01194063: Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children
Official title: Use of Omegaven for Parenteral Nutrition Associated Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholestasis
Keywords: short bowel syndrome
parenteral nutrition associated liver disease
pediatric
Lead sponsor: Kapiolani Medical Center For Women & Children
Sponsor class: OTHER
First posted: 2010-09-02
Enrollment: 36
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.

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 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

Primary outcomes:
measure: improving cholestasis
timeFrame: One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment
Secondary outcomes:
measure: improving liver function tests
timeFrame: 1 year
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
Study officials:
affiliation: Kapiolani Medical Center For Women & Children
name: Lynn M Iwamoto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee SI, Valim C, Johnston P, Le HD, Meisel J, Arsenault DA, Gura KM, Puder M. Impact of fish oil-based lipid emulsion on serum triglyceride, bilirubin, and albumin levels in children with parenteral nutrition-associated liver disease. Pediatr Res. 2009 Dec;66(6):698-703. doi: 10.1203/PDR.0b013e3181bbdf2b.
citation: de Meijer VE, Le HD, Meisel JA, Gura KM, Puder M. Parenteral fish oil as monotherapy prevents essential fatty acid deficiency in parenteral nutrition-dependent patients. J Pediatr Gastroenterol Nutr. 2010 Feb;50(2):212-8. doi: 10.1097/MPG.0b013e3181bbf51e.