Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition
Status:
Completed
Trial end date:
2016-06-30
Target enrollment:
Participant gender:
Summary
The aim of this study was to evaluate the safety and tolerance of ClinOleic or Lipoplus or
SMOFlipid lipid emulsions. After 6 weeks of each lipid emulsion, Omegaven (fish oil) was
added for a further 4 weeks. The safety and tolerance was evaluated after each lipid emulsion
cycle by biochemistry, hematology and coagulation variables, vital signs and adverse events.
We also analysed fatty acid profiles in plasma or erythrocyte phospholipids, antioxidant
enzyme activities, lipid peroxidation products, plasma lipids and pro-inflammatory cytokine
production after in vitro stimulation of whole blood by lipopolysacharide in HPN patients.
The non-interventional group of healthy controls was included for comparison.
Phase:
Phase 4
Details
Lead Sponsor:
General University Hospital, Prague
Collaborators:
Charles University, Czech Republic Ministry of Health, Czech Republic