SMOFLipid in Patients Who Are Intralipid Intolerant

NCT03054948 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 16-009516
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Home Parenteral Nutrition; Short Bowel Syndrome

Outcome Measures

Primary Outcomes (6)

• AST

  Primary aim is to assess impact on AST (liver enzyme)

  3-12 months

• Glucose

  blood glucose

  3-12 months

• Triglycerides

  blood triglycerides

  3-12 months

• ALT

  liver enzyme

  3-12 months

• Total bilirubin

  Liver study

  3-12 months

• CRP

  inflammatory marker

  3-12 months

Study Arms (2)

SMOFLipid

EXPERIMENTAL

Patients in this arm with be randomized to SMOFlipid as their lipid emulsion

Drug: SMOFLipid

Standard therapy

ACTIVE COMPARATOR

Patients in this arm will be continue with their current lipid emulsion

Drug: Standard therapy

Interventions

SMOFLipid DRUG

SMOFlipid is a lipid emulsion formed using soybean oil, medium chain triglycerides, olive oil, and fish oil.

SMOFLipid

Standard therapy DRUG

In most cases standard therapy will be IntraLipid.

Standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

SMOFlipid; Standard of Care

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Manpreet S Mundi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 16, 2017
• Study Start: February 1, 2017
• Primary Completion: March 20, 2018
• Study Completion: March 20, 2018
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

US (1)