NCT03054948

SMOFLipid in Patients Who Are Intralipid Intolerant

Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Home Parenteral Nutrition
• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	SMOFLipid	SMOFlipid is a lipid emulsion formed using soybean oil, medium chain triglycerides, olive oil, and fish oil.
DRUG	Standard therapy	In most cases standard therapy will be IntraLipid.

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-03-20
• Completion: 2018-03-20
• First posted: 2017-02-16
• Last updated: 2018-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study