NCT03149653

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

A Prospective, Randomized, Controlled, Double-blind, Crossover-Design, Mono-center, Phase IV Study Comparing the Effect of Omegaven in Combination With Clinoleic or Lipoplus or SMOFlipid in Home Parenteral Nutrition Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: General University Hospital, Prague · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Intravenous lipid emulsions (LEs) are an indispensable part of home parenteral nutrition (HPN). All commercially obtainable LEs are applicable for HPN in providing a source of energy and essential fatty acids. The originally used soyabean oil-based LE (Intralipid) have been suspected of being associated with a higher risk of pro-inflammatory lipid-mediator production due to their high content of n-6 polyunsaturated fatty acids. The more modern mixes of soyabean oil, and/or olive oil, and/or fish oil LEs with beneficial responses compared with Intralipid are available. Given that there are no clear clinical recommendations for LE application in HPN, we performed this cross-over design, phase 4 study comparing ClinOleic, Lipoplus or SMOFlipid in chronic intestinal failure patients with additional escalation of fish oil using Omegaven.

Conditions

• Parenteral Nutrition

Interventions

Type	Name	Description
DRUG	ClinOleic (baseline)	Lipid emulsion in pharmacy compounded all-in-one admixture
DRUG	ClinOleic + Omegaven	Lipid emulsion in pharmacy compounded all-in-one admixture
DRUG	Lipoplus (baseline)	Lipid emulsion in pharmacy compounded all-in-one admixture
DRUG	Lipoplus + Omegaven	Lipid emulsion in pharmacy compounded all-in-one admixture
DRUG	SMOFlipid (baseline)	Lipid emulsion in pharmacy compounded all-in-one admixture
DRUG	SMOFlipid + Omegaven	Lipid emulsion in pharmacy compounded all-in-one admixture

Timeline

• Start date: 2012-01-15
• Primary completion: 2016-01-07
• Completion: 2016-06-30
• First posted: 2017-05-11
• Last updated: 2017-05-11

Locations

1 site across 1 country: Czechia