Intralipid Versus SMOFlipid in HPN Patients

NCT03773237 — Not applicable, Completed, 22 participants, Mayo Clinic

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

Registry	NCT03773237
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, supportive care
Enrollment	22 (Actual)
Sponsor	Mayo Clinic (Other)
Conditions	Short Bowel Syndrome, Intestinal Fistula, Crohn Disease, Intestinal Obstruction
Interventions	SMOFLipid, Intralipid (Dietary supplement)
Dates	start 2018-12-31, primary completion 2023-12-01, completion 2024-10-01, first posted 2018-12-12, last updated 2025-05-16
Locations	1 site in United States

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
SMOFLipid	Active comparator	Dietary Supplement: SMOFLipid	SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.
IntraLipid	Active comparator	Dietary Supplement: Intralipid	Intralipid is a lipid emulsion that contains soybean oil

SMOFLipid (Dietary supplement): SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
Intralipid (Dietary supplement): Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid

+Outcome measures

Primary outcomes

Direct/Indirect Bilirubin Change is assessed [At 12 weeks weeks]: mg/dL

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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.

+Locations (1)

Facility	City	Country	Status
Mayo Clinic in Rochester	Rochester, Minnesota	United States

+Investigators

Manpreet S Mundi, MD, Principal investigator, Mayo Clinic