SMOFLipid in Patients Who Are Intralipid Intolerant
Withdrawn before enrolling · Phase 4
Conditions studied: Home Parenteral Nutrition, Short Bowel Syndrome
In brief
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.
Key facts
- Study ID
- NCT03054948
- Run by
- Mayo Clinic
- People needed
- 0
- Starts
- 2017-02-01
- Expected to finish
- 2018-03-20
- Last updated by the study team
- 2018-03-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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