Back to resultsSMOFLipid in Patients Who Are Intralipid Intolerant
Primary Purpose
Home Parenteral Nutrition, Short Bowel Syndrome
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
SMOFLipid
Standard therapy
Sponsored by
About this trial
This is an interventional treatment trial for Home Parenteral Nutrition
Eligibility 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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SMOFLipid
Standard therapy
Arm Description
Patients in this arm with be randomized to SMOFlipid as their lipid emulsion
Patients in this arm will be continue with their current lipid emulsion
Outcomes
Primary Outcome Measures
AST
Primary aim is to assess impact on AST (liver enzyme)
Glucose
blood glucose
Triglycerides
blood triglycerides
ALT
liver enzyme
Total bilirubin
Liver study
CRP
inflammatory marker
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03054948
Brief Title
SMOFLipid in Patients Who Are Intralipid Intolerant
Official Title
Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Redesign of study protocol.
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
March 20, 2018 (Anticipated)
Study Completion Date
March 20, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Home Parenteral Nutrition, Short Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMOFLipid
Arm Type
Experimental
Arm Description
Patients in this arm with be randomized to SMOFlipid as their lipid emulsion
Arm Title
Standard therapy
Arm Type
Active Comparator
Arm Description
Patients in this arm will be continue with their current lipid emulsion
Intervention Type
Drug
Intervention Name(s)
SMOFLipid
Intervention Description
SMOFlipid is a lipid emulsion formed using soybean oil, medium chain triglycerides, olive oil, and fish oil.
Intervention Type
Drug
Intervention Name(s)
Standard therapy
Intervention Description
In most cases standard therapy will be IntraLipid.
Primary Outcome Measure Information:
Title
AST
Description
Primary aim is to assess impact on AST (liver enzyme)
Time Frame
3-12 months
Title
Glucose
Description
blood glucose
Time Frame
3-12 months
Title
Triglycerides
Description
blood triglycerides
Time Frame
3-12 months
Title
ALT
Description
liver enzyme
Time Frame
3-12 months
Title
Total bilirubin
Description
Liver study
Time Frame
3-12 months
Title
CRP
Description
inflammatory marker
Time Frame
3-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manpreet S Mundi
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
SMOFLipid in Patients Who Are Intralipid Intolerant
We'll reach out to this number within 24 hrs