<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03773237</url>
  </required_header>
  <id_info>
    <org_study_id>17-001403</org_study_id>
    <nct_id>NCT03773237</nct_id>
  </id_info>
  <brief_title>Intralipid Versus SMOFlipid in HPN Patients</brief_title>
  <official_title>Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will randomize all patients who are new to the Mayo Clinic HPN team to either&#xD;
      standard lipid emulsion (Intralipid) or SMOFLipid.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary aim is to assess the impact to direct bilirubin.&#xD;
&#xD;
      Secondary aims will be to assess impact to other liver function studies, metabolic&#xD;
      parameters, inflammatory marker, body weight, ability to meet caloric needs through TPN, and&#xD;
      ability to obtain appropriate macronutrient composition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 31, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective Randomized Controlled</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Direct Bilirubin Change is assessed</measure>
    <time_frame>At 12 weeks weeks</time_frame>
    <description>mg/dL</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Short Bowel Syndrome</condition>
  <condition>Intestinal Fistula</condition>
  <condition>Crohn Disease</condition>
  <condition>Intestinal Obstruction</condition>
  <arm_group>
    <arm_group_label>SMOFLipid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IntraLipid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intralipid is a lipid emulsion that contains soybean oil</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>SMOFLipid</intervention_name>
    <description>SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.</description>
    <arm_group_label>SMOFLipid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Intralipid</intervention_name>
    <description>Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid</description>
    <arm_group_label>IntraLipid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly initiated Mayo Clinic HPN patient&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Anticipated duration of HPN greater than 3 months,&#xD;
&#xD;
          -  Infusion company is able to provide Smoflipid&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Failure to provide consent&#xD;
&#xD;
          -  Patients with underlying liver dysfunction (defined as liver function studies equal to&#xD;
             or more than 2 times upper limit of normal) or pathology as determined by primary&#xD;
             investigator&#xD;
&#xD;
          -  Patients with active malignancy&#xD;
&#xD;
          -  Patients who are deemed to be on HPN for less than three months&#xD;
&#xD;
          -  Patients who have previous proven addiction and dependence to alcohol/ heavy alcohol&#xD;
             AND consumption/active use reported during last 12 months.&#xD;
&#xD;
          -  Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the&#xD;
             active ingredients or excipients in Smoflipid&#xD;
&#xD;
          -  Patients who will not be managed by the Mayo Clinic HPN team&#xD;
&#xD;
          -  Patients who have active infection (as determined by the clinician) at the time of&#xD;
             enrollment.&#xD;
&#xD;
          -  Patients who have received Smoflipid greater than 4 weeks in the last 12 months prior&#xD;
             to enrollment.&#xD;
&#xD;
          -  Patients who have been on TPN greater than 4 weeks in the last 12 months prior to&#xD;
             enrollment.&#xD;
&#xD;
          -  Enrolled in another interventional study.&#xD;
&#xD;
          -  Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides&#xD;
             more than 1,000 mg/dL.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manpreet S Mundi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Manpreet S. Mundi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>SMOF</keyword>
  <keyword>Intralipid</keyword>
  <keyword>Mixed oil emulsion</keyword>
  <keyword>Intestinal failure</keyword>
  <keyword>HPN</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Short Bowel Syndrome</mesh_term>
    <mesh_term>Intestinal Obstruction</mesh_term>
    <mesh_term>Intestinal Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Soybean oil, phospholipid emulsion</mesh_term>
    <mesh_term>SMOFlipid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03773237
org study id: 17-001403
nct id: NCT03773237
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will randomize all patients who are new to the Mayo Clinic HPN team to either
      standard lipid emulsion (Intralipid) or SMOFLipid.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective Randomized Controlled
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
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.
measure: Direct Bilirubin Change is assessed
time frame: At 12 weeks weeks
description: mg/dL
arm group label: SMOFLipid
arm group type: Active Comparator
description: SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.
arm group label: IntraLipid
arm group type: Active Comparator
description: Intralipid is a lipid emulsion that contains soybean oil
intervention type: Dietary Supplement
intervention name: SMOFLipid
description: SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
arm group label: SMOFLipid
intervention type: Dietary Supplement
intervention name: Intralipid
description: Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid
arm group label: IntraLipid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Manpreet S Mundi, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Manpreet S. Mundi
investigator title: Principal Investigator
mesh term: Crohn Disease
mesh term: Short Bowel Syndrome
mesh term: Intestinal Obstruction
mesh term: Intestinal Fistula
mesh term: Fistula
mesh term: Soybean oil, phospholipid emulsion
mesh term: SMOFlipid
sharing ipd: No