drugset

drugset / Trial / NCT01194063

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

NCT01194063 ↗

Phase 3 Completed 36 enrolled Kapiolani Medical Center For Women & Children

NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2010-10-20
Primary completion: 2018-11-30
Completion: 2019-01-15

Publications

Background 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.
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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omegaven	Other / unclassified	1 g/kg	Intravenous

Indications