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SMOFLipid in Patients Who Are Intralipid Intolerant

NCT03054948 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-03-22

No results posted yet for this study

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.

Conditions

  • Home Parenteral Nutrition
  • Short Bowel Syndrome

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Manpreet S Mundi · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-03-20
Completion
2018-03-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03054948 on ClinicalTrials.gov