drugset / Trial / NCT03054948

SMOFLipid in Patients Who Are Intralipid Intolerant

NCT03054948 ↗

Phase 4 Withdrawn Mayo Clinic
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2017-02-01
Primary completion
2018-03-20
Completion
2018-03-20

Outcome

Outcome not reported

Stopped: “Redesign of study protocol.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Intralipid Other / unclassified — —
Subject SMOFlipid Other / unclassified — —

Indications