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OpenTrials
Completed

NCT Number: NCT03773237

Intralipid Versus SMOFlipid in 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.

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Direct/Indirect Bilirubin Change is assessed

    Time frame: At 12 weeks weeks

    mg/dL

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Dec 12, 2018
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.