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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03773237
Other study ID # 17-001403
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 31, 2018
Est. completion date September 2024

Study information

Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 22
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Direct Bilirubin Change is assessed mg/dL At 12 weeks weeks
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