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drugset / Trial / NCT03149653

Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition

NCT03149653 ↗

Phase 4 Completed 24 enrolled General University Hospital, Prague Charles University, Czech Republic · collabMinistry of Health, Czech Republic · collab
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2012-01-15
Primary completion
2016-01-07
Completion
2016-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject ClinOleic Other / unclassified 40 g Intravenous
Subject ClinOleic Other / unclassified 50 g Intravenous
Subject Lipoplus Other / unclassified 40 g Intravenous
Subject Lipoplus Other / unclassified 50 g Intravenous
Subject Omegaven Other / unclassified 10 g Intravenous
Subject SMOFlipid Other / unclassified 40 g Intravenous
Subject SMOFlipid Other / unclassified 50 g Intravenous

Indications

No indication recorded.