drugset / Trial / NCT03044639

Parenteral Lipid Emulsions and the Liver Function

NCT03044639

Phase 4 Completed 64 enrolled Stanley Dudrick's Memorial Hospital
RandomizedParallel-groupSingle-blindPrevention

Summary

The randomized, double-blind, multi-centric study performed in four parallel groups to compare all lipid emulsions, which can be used as a part of PN. Patients with home parenteral nutrition due to stable intestinal failure, were randomly assigned to receive parenteral nutrition with one the following lipid emulsions: * Long-chained triglycerides (LCT group) * Medium/ long-chained triglycerides MCT/LCT (50:50, MCT/LCT group)) * Olive oil/ LCT (80:20, OO group)) * SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group)

Timeline

Start
2010-04-01
Primary completion
2016-10-31
Completion
2016-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Long-chained triglycerides Other / unclassified 0.8 g/kg Intravenous
Subject Long-chained triglycerides Other / unclassified 1 g/kg Intravenous
Subject Medium/ long-chained triglycerides Other / unclassified 0.8 g/kg Intravenous
Subject Medium/ long-chained triglycerides Other / unclassified 1 g/kg Intravenous
Subject Olive oil Other / unclassified 0.8 g/kg Intravenous
Subject Olive oil Other / unclassified 1 g/kg Intravenous
Subject SMOFlipid Other / unclassified 0.8 g/kg Intravenous
Subject SMOFlipid Other / unclassified 1 g/kg Intravenous

Indications