Intralipid Versus SMOFlipid in HPN Patients | NCT03773237

Studies
Intralipid Versus SMOFlipid in HPN Patients

NCT03773237

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

May 16, 2025Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Short Bowel Syndrome
Intestinal Fistula
Crohn Disease
Intestinal Obstruction

Interventions

SMOFLipid
Intralipid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2018Actual

Primary Completion Date

Dec 1, 2023Actual

Completion Date

Oct 1, 2024Actual

First Submitted Date

Nov 12, 2018

First Submission Date that Met QC Criteria

Dec 10, 2018

First Posted Date

Dec 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2025

Last Update Posted Date

May 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SMOFLipid	Dietary Supplement	SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.	SMOFLipid

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Manpreet S Mundi, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012778	Short Bowel Syndrome
D007412	Intestinal Fistula
D003424	Crohn Disease
D007415	Intestinal Obstruction
D000090124	Intestinal Failure

Ancestor Terms

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
C000709826	SMOFlipid
C545823	soybean oil, phospholipid emulsion

Masking Info

Masking

Triple

Masking Description

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.

Who Masked

ParticipantCare ProviderInvestigator