SMOFLipid in Patients Who Are Intralipid Intolerant

March 20, 2018 updated by: Manpreet S. Mundi, Mayo Clinic

Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Manpreet S Mundi, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Anticipated)

March 20, 2018

Study Completion (Anticipated)

March 20, 2018

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-009516

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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