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Trial record 58 of 181 for:    Phospholipids

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Recruitment Status : Withdrawn (Redesign of study protocol.)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

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.

Condition or disease Intervention/treatment Phase
Home Parenteral Nutrition Short Bowel Syndrome Drug: SMOFLipid Drug: Standard therapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : March 20, 2018
Estimated Study Completion Date : March 20, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: SMOFlipid

Arm Intervention/treatment
Experimental: SMOFLipid
Patients in this arm with be randomized to SMOFlipid as their lipid emulsion
Drug: SMOFLipid
SMOFlipid is a lipid emulsion formed using soybean oil, medium chain triglycerides, olive oil, and fish oil.

Active Comparator: Standard therapy
Patients in this arm will be continue with their current lipid emulsion
Drug: Standard therapy
In most cases standard therapy will be IntraLipid.




Primary Outcome Measures :
  1. AST [ Time Frame: 3-12 months ]
    Primary aim is to assess impact on AST (liver enzyme)

  2. Glucose [ Time Frame: 3-12 months ]
    blood glucose

  3. Triglycerides [ Time Frame: 3-12 months ]
    blood triglycerides

  4. ALT [ Time Frame: 3-12 months ]
    liver enzyme

  5. Total bilirubin [ Time Frame: 3-12 months ]
    Liver study

  6. CRP [ Time Frame: 3-12 months ]
    inflammatory marker



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054948


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Manpreet S Mundi Mayo Clinic

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Responsible Party: Manpreet S. Mundi, Assistant Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03054948     History of Changes
Other Study ID Numbers: 16-009516
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Soybean oil, phospholipid emulsion
Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions