NCT01739517

Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Amarnath, Rathna, M.D. · Individual
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This pilot study seeks to demonstrate the efficacy of an intravenous lipid preparation high in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition dependent patients with short gut syndrome.

Conditions

• Short Bowel Syndrome
• Cholestasis

Interventions

Type	Name	Description
DRUG	Omegaven Therapy	After baseline labs, which have been collected no earlier than seven days prior to the initiation of therapy are obtained, therapy with Omegaven will be initiated at a starting dose of 0.5 g/kg/day infused over 12 hours. If tolerated, the dose will be increased to 1 g/kg/day, the goal dose. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-12-03
• Last updated: 2012-12-03

Locations

1 site across 1 country: United States