SMOFLipid in Patients Who Are Intralipid Intolerant

Sponsor

Mayo Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03054948

Collaborator

(none)

Enrollment

Location

Arms

13.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

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 :

Feb 1, 2017

Anticipated Primary Completion Date :

Mar 20, 2018

Anticipated Study Completion Date :

Mar 20, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Manpreet S Mundi, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Manpreet S. Mundi, Assistant Professor, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03054948

Other Study ID Numbers:

16-009516

First Posted:

Feb 16, 2017

Last Update Posted:

Mar 22, 2018

Last Verified:

Mar 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Short Bowel Syndrome

SMOFlipid

Study Results

No Results Posted as of Mar 22, 2018