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

NCT01194063 | Completed Phase 3 DMC

• 1 other identifier: 107954
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholestasis

Keywords

short bowel syndrome; parenteral nutrition associated liver disease; pediatric

Outcome Measures

Primary Outcomes (1)

• improving cholestasis

  decline in serum direct bilirubin levels below 2 cm on 2 serial measures

  One month, 2 months, 3 months after starting omegaven and 1 month after completing treatment

Secondary Outcomes (1)

• improving liver function tests

  1 year

Study Arms (1)

Omegaven

EXPERIMENTAL

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

Interventions

Omega-3 fish oil lipid emulsion DRUG

daily intravenous administration of Omegaven fish oil emulsion

Also known as: Omegaven

Omegaven

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kapiolani Medical Center For Women & Children: lead

Study Sites (1)

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Related Publications (2)

• 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.

  PMID: 19687773 BACKGROUND

• 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.

  PMID: 20038849 BACKGROUND

MeSH Terms

Conditions

Cholestasis; Short Bowel Syndrome

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lynn M Iwamoto, MD

  Kapiolani Medical Center For Women & Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor of Pediatrics

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: September 2, 2010
• Study Start: October 20, 2010
• Primary Completion: November 30, 2018
• Study Completion: January 15, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (1)