SMOFLipid in Patients Who Are Intralipid Intolerant

Overview

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.

Full Title of Study: “Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: March 20, 2018

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: SMOFLipid
    • Patients in this arm with be randomized to SMOFlipid as their lipid emulsion
  • Active Comparator: Standard therapy
    • Patients in this arm will be continue with their current lipid emulsion

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Manpreet S. Mundi, Assistant Professor – Mayo Clinic
  • Overall Official(s)
    • Manpreet S Mundi, Principal Investigator, Mayo Clinic

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