NCT00451646

Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Fresenius Kabi · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and coagulation variables, vital signs and adverse events. Further objectives to evaluate are the influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red blood cells and serum.

Conditions

• Parenteral Nutrition

Interventions

Type	Name	Description
DRUG	SMOF lipid and Intralipid	1-2 g, 5-7 days, 28 days

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-10-01
• Completion: 2008-11-01
• First posted: 2007-03-23
• Last updated: 2010-08-27

Locations

12 sites across 7 countries: Australia, Denmark, France, Israel, Netherlands, Poland, United Kingdom