SMOFLipid in Patients Who Are Intralipid Intolerant

Phase 4

Withdrawn

• Conditions: Home Parenteral Nutrition; Short Bowel Syndrome
• Interventions: Drug: SMOFLipid; Drug: Standard therapy

• Registration Number: NCT03054948
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Status Verified: 2018-03
• Primary Completion: 2018-03-20
• Study Completion: 2018-03-20
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age greater than 18 years
• current Mayo Clinic HPN patient, able to provide informed consent, anticipated duration of HPN greater than 3 months
• infusion company is able to provide SMOFlipid
• no history of alcohol addiction
• noted to be intolerant to SO based IVFE as defined below.

Exclusion Criteria

• Pregnant women
• failure to provide consent
• patients who are deemed to be on HPN for less than three months
• patients who have previous proven addiction and dependence to alcohol/ heavy alcohol consumption reported (during history or reported in the EMR), known hypersensitivity to fish, egg, or soy, patients who will not be managed by the Mayo Clinic HPN team and patients who have active infection (as determined by the clinician) at the time of enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMOFLipid	SMOFLipid	Patients in this arm with be randomized to SMOFlipid as their lipid emulsion
Standard therapy	Standard therapy	Patients in this arm will be continue with their current lipid emulsion

Primary Outcome Measures

Name	Time	Method
AST	3-12 months	Primary aim is to assess impact on AST (liver enzyme)
Glucose	3-12 months	blood glucose
Triglycerides	3-12 months	blood triglycerides
ALT	3-12 months	liver enzyme
Total bilirubin	3-12 months	Liver study
CRP	3-12 months	inflammatory marker

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States