Intralipid Versus SMOFlipid in HPN Patients

Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.

This study will randomize all patients who are new to the Mayo Clinic HPN team to either standard lipid emulsion (Intralipid) or SMOFLipid.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Intestinal Fistula; Intestinal Obstruction; Short Bowel Syndrome
• Intervention / Treatment: Dietary supplement: SMOFLipid; Dietary supplement: Intralipid

Detailed Description

Primary aim is to assess the impact to direct/indirect bilirubin.

Secondary aims will be to assess impact to other liver function studies, metabolic parameters, inflammatory marker, body weight, ability to meet caloric needs through TPN, and ability to obtain appropriate macronutrient composition.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Newly initiated Mayo Clinic HPN patient
• Able to provide informed consent
• Anticipated duration of HPN greater than 3 months,
• Infusion company is able to provide Smoflipid

Exclusion Criteria:

• Age less than 18 years
• Pregnant and lactating women
• Failure to provide consent
• Patients with underlying liver dysfunction (defined as liver function studies equal to or more than 2 times upper limit of normal) or pathology as determined by primary investigator
• Patients with active malignancy
• 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 AND consumption/active use reported during last 12 months.
• Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients in Smoflipid
• Patients who will not be managed by the Mayo Clinic HPN team
• Patients who have active infection (as determined by the clinician) at the time of enrollment.
• Patients who have received Smoflipid greater than 4 weeks in the last 12 months prior to enrollment.
• Patients who have been on TPN greater than 4 weeks in the last 12 months prior to enrollment.
• Enrolled in another interventional study.
• Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides more than 1,000 mg/dL.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SMOFLipid; SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.	Dietary supplement: SMOFLipid; SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
Active Comparator: IntraLipid; Intralipid is a lipid emulsion that contains soybean oil	Dietary supplement: Intralipid; Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct/Indirect Bilirubin Change is assessed	mg/dL	At 12 weeks weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Manpreet S Mundi, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2018
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Intralipid; SMOF; Intestinal failure; HPN; Mixed oil emulsion
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Malabsorption Syndromes; Digestive System Fistula; Crohn Disease; Short Bowel Syndrome; Intestinal Fistula; Fistula; Intestinal Obstruction; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; SMOFlipid; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: 17-001403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No