Overview

SMOFLipid in Patients Who Are Intralipid Intolerant

Status:
Withdrawn
Trial end date:
2018-03-20
Target enrollment:
Participant gender:
Summary
Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US. Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be associated with a number of complications including inflammation, abnormal liver function tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of intolerance to soybean oil IVFE. This study is designed to investigate the impact of SMOFlipid in prolonged use.
Phase:
Phase 4
Details
Lead Sponsor:
Mayo Clinic
Treatments:
SMOFlipid
Soybean oil, phospholipid emulsion