Intralipid Versus SMOFlipid in HPN Patients
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|ClinicalTrials.gov Identifier: NCT03773237|
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : January 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Short Bowel Syndrome Intestinal Fistula Crohn Disease Intestinal Obstruction||Dietary Supplement: SMOFLipid Dietary Supplement: Intralipid||Not Applicable|
Primary aim is to assess the impact to direct 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective Randomized Controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.|
|Actual Study Start Date :||December 31, 2018|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||May 1, 2022|
Active Comparator: SMOFLipid
SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.
Dietary Supplement: SMOFLipid
SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
Active Comparator: IntraLipid
Intralipid is a lipid emulsion that contains soybean oil
Dietary Supplement: Intralipid
Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid
- Direct Bilirubin Change is assessed [ Time Frame: At 12 weeks weeks ]mg/dL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773237
|Contact: Manpreet S Mundi, MD||507-284-4080||Mundi.Manpreet@mayo.edu|
|Contact: Vishakantha (Vishu) Murthy, PhD||507-255-8112||Murthy.Vishakantha@mayo.edu|
|Principal Investigator:||Manpreet S Mundi, MD||Mayo Clinic|