NCT03773237Completed
Intralipid Versus SMOFlipid in HPN Patients
Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.
Source: ClinicalTrials.gov · Last updated 16 May 2025
Brief summary (registry, in English)
This study will randomize all patients who are new to the Mayo Clinic HPN team to either standard lipid emulsion (Intralipid) or SMOFLipid.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 12 Nov 2018
- Start date
- 31 Dec 2018
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- Mayo Clinic
- Diseases
- Crohn's disease
- NCT number
- NCT03773237
What you commit to
- Study type: Interventional
- Participants enrolled: 22
- From 31 Dec 2018 to the primary completion date, 1 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previous proven addiction and dependence to alcohol/ heavy alcohol AND consumption/active use reported during last 12 months.
- 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.
Other illness
- Failure to provide consent
- Patients with active malignancy
- Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients in Smoflipid
- Patients who have active infection (as determined by the clinician) at the time of enrollment.
Lab values
- Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides more than 1,000 mg/dL.
Age
- Age less than 18 years
Other
- Pregnant and lactating women
- 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 who are deemed to be on HPN for less than three months
- Patients who will not be managed by the Mayo Clinic HPN team
- Enrolled in another interventional study.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.