Intralipid Versus SMOFlipid in HPN Patients

NCT03773237 | Completed DMC

• 1 other identifier: 17-001403
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Short Bowel Syndrome; Intestinal Fistula; Crohn Disease; Intestinal Obstruction

Keywords

SMOF; Intralipid; Mixed oil emulsion; Intestinal failure; HPN

Outcome Measures

Primary Outcomes (1)

• Direct/Indirect Bilirubin Change is assessed

  mg/dL

  At 12 weeks weeks

Study Arms (2)

SMOFLipid

ACTIVE COMPARATOR

SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.

Dietary Supplement: SMOFLipid

IntraLipid

ACTIVE COMPARATOR

Intralipid is a lipid emulsion that contains soybean oil

Dietary Supplement: Intralipid

Interventions

SMOFLipid DIETARY_SUPPLEMENT

SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.

SMOFLipid

Intralipid DIETARY_SUPPLEMENT

Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid

IntraLipid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Short Bowel Syndrome; Intestinal Fistula; Crohn Disease; Intestinal Obstruction; Intestinal Failure

Interventions

SMOFlipid; soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Inflammatory Bowel Diseases; Gastroenteritis

Study Officials

• Manpreet S Mundi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The randomization list will be generated using http://www.randomization.com and blinded at enrollment using supplement codes. The study coordinator will hold the randomization codes and will be revealed to the investigators only after the statistical analysis is complete.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective Randomized Controlled

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: December 12, 2018
• Study Start: December 31, 2018
• Primary Completion: December 1, 2023
• Study Completion: October 1, 2024
• Last Updated: May 16, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)