Viewing Study NCT03149653



Ignite Creation Date: 2024-05-06 @ 10:02 AM
Last Modification Date: 2024-10-26 @ 12:24 PM
Study NCT ID: NCT03149653
Status: COMPLETED
Last Update Posted: 2017-05-11
First Post: 2017-04-11

Brief Title: Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition
Sponsor: General University Hospital Prague
Organization: General University Hospital Prague

Study Overview

Official Title: 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
Status Verified Date: 2017-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 andor olive oil andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None