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SMOFLipid in Patients Who Are Intralipid Intolerant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054948
Recruitment Status : Withdrawn (Redesign of study protocol.)
First Posted : February 16, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Manpreet S. Mundi, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE February 8, 2017
First Posted Date  ICMJE February 16, 2017
Last Update Posted Date March 22, 2018
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date March 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03054948 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SMOFLipid in Patients Who Are Intralipid Intolerant
Official Title  ICMJE Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Home Parenteral Nutrition
  • Short Bowel Syndrome
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: SMOFLipid
    Patients in this arm with be randomized to SMOFlipid as their lipid emulsion
    Intervention: Drug: SMOFLipid
  • Active Comparator: Standard therapy
    Patients in this arm will be continue with their current lipid emulsion
    Intervention: Drug: Standard therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 20, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2017)
60
Estimated Study Completion Date  ICMJE March 20, 2018
Estimated Primary Completion Date March 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03054948
Other Study ID Numbers  ICMJE 16-009516
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manpreet S. Mundi, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manpreet S Mundi Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP