<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/NCT04467138</url>
  </required_header>
  <id_info>
    <org_study_id>Omegaven</org_study_id>
    <nct_id>NCT04467138</nct_id>
  </id_info>
  <brief_title>High Dose Intravenous Fish Oil Reduces Inflammation</brief_title>
  <official_title>High Dose Intravenous Fish Oil Reduces Inflammation and Improves Liver Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanley Dudrick's Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanley Dudrick's Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who&#xD;
      received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish&#xD;
      oil LE was performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients depended on parenteral nutrition (PN) are prone to inflammation. This condition&#xD;
      may aggravate already existing proinflammatory status and can become a critical factor for&#xD;
      developing liver dysfunction (LD). Intravenous fish oil may attenuate the inflammatory&#xD;
      status, , however, data on its use in adults is scarce. The aim of the study was to&#xD;
      investigate the impact of the addition of pure fish oil intravenous lipid emulsion (ILE) as&#xD;
      part of short- and long term PN in patients either at risk or with already existing&#xD;
      inflammation.&#xD;
&#xD;
      Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who&#xD;
      received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish&#xD;
      oil LE was performed. Pure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the&#xD;
      additional product along with the standard lipid emulsion to reach a fish oil dose of approx.&#xD;
      0.5 g fish oil/kg/d. Diagnoses were chronic intestinal failure (CIF, n=20), Crohn's disease&#xD;
      (CD, n=22), and Ulcerative colitis (UC, n=19). The observation period was 12 months for CIF&#xD;
      and 21days for UC and CD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in hsCRP concentration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Serum concentration of hsCRP (pg/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Il-6 concentration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Serum concentration of Il-6 (pg/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in interleukin-10 concentration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Serum concentration of IL-10 (pg/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in procalcytonin concentration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Serum concentration of procalcytonin (ng/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in bilirubin concentration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Serum concentration of bilirubin (umol/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in SGPT concentration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Serum concentration of SGPT(U/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in SGOT concentration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Serum concentration of SGOT (U/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in alkaline phosphatase concentration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Serum concentration of alkaline phosphatase (U/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in C-reactive protein concentration</measure>
    <time_frame>4 weeks</time_frame>
    <description>Serum concentration of CRP (mg/l)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">51</enrollment>
  <condition>Lipid Metabolism Disorders</condition>
  <arm_group>
    <arm_group_label>Inflammatory bowel disease</arm_group_label>
    <description>Patients with either Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic intestinal failure</arm_group_label>
    <description>Patients with intestinal failure (CIF, n=20)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omegaven</intervention_name>
    <description>Pure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the additional product along with the standard lipid emulsion to reach a fish oil dose of approx. 0.5 g fish oil/kg/d.</description>
    <arm_group_label>Chronic intestinal failure</arm_group_label>
    <arm_group_label>Inflammatory bowel disease</arm_group_label>
    <other_name>Fish oil</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with either inflammatory bowel disease or chronic intestinal failure. Both in and&#xD;
        out patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years of age,&#xD;
&#xD;
          -  metabolic stability (the absence of pathological laboratory resulting in the change of&#xD;
             PN regime for at least one month)&#xD;
&#xD;
          -  ability to tolerate up to 1.0 g lipids/kg body weight per day as a part of PN.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with a history of cancer and anti-cancer treatment within the last 5 years,&#xD;
             severe hyperlipidemia, severe coagulopathy, severe renal insufficiency, acute&#xD;
             thromboembolic events, positive test for HIV, Hepatitis B or C (from medical history),&#xD;
             known or suspected drug or alcohol abuse, participation in another interventional&#xD;
             clinical trial in parallel or within three months prior to the start of this clinical&#xD;
             trial, for women with childbearing potential (i.e. females who are not chemically or&#xD;
             surgically sterile or females who are not postmenopausal) or women of childbearing&#xD;
             potential tested positive on standard pregnancy test (urine dipstick) or/and&#xD;
             lactation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stanislaw Klek, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>1972</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanley Dudrick's Memorial Hospital</name>
      <address>
        <city>Skawina</city>
        <zip>32-050</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <results_reference>
    <citation>Klek S, Szczepanek K, Scislo L, Walewska E, Pietka M, Pisarska M, Pedziwiatr M. Intravenous lipid emulsions and liver function in adult chronic intestinal failure patients: results from a randomized clinical trial. Nutrition. 2018 Nov;55-56:45-50. doi: 10.1016/j.nut.2018.03.008. Epub 2018 Mar 22.</citation>
    <PMID>29960156</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanley Dudrick's Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Stanislaw Klek</investigator_full_name>
    <investigator_title>Head of the Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Lipid Metabolism Disorders</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_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/NCT04467138
org study id: Omegaven
nct id: NCT04467138
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who
      received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish
      oil LE was performed.
All patients depended on parenteral nutrition (PN) are prone to inflammation. This condition
      may aggravate already existing proinflammatory status and can become a critical factor for
      developing liver dysfunction (LD). Intravenous fish oil may attenuate the inflammatory
      status, , however, data on its use in adults is scarce. The aim of the study was to
      investigate the impact of the addition of pure fish oil intravenous lipid emulsion (ILE) as
      part of short- and long term PN in patients either at risk or with already existing
      inflammation.

      Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who
      received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish
      oil LE was performed. Pure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the
      additional product along with the standard lipid emulsion to reach a fish oil dose of approx.
      0.5 g fish oil/kg/d. Diagnoses were chronic intestinal failure (CIF, n=20), Crohn's disease
      (CD, n=22), and Ulcerative colitis (UC, n=19). The observation period was 12 months for CIF
      and 21days for UC and CD.
observational model: Cohort
time perspective: Retrospective
measure: Change in hsCRP concentration
time frame: 4 weeks
description: Serum concentration of hsCRP (pg/mL)
measure: Change in Il-6 concentration
time frame: 4 weeks
description: Serum concentration of Il-6 (pg/mL)
measure: Change in interleukin-10 concentration
time frame: 4 weeks
description: Serum concentration of IL-10 (pg/mL)
measure: Change in procalcytonin concentration
time frame: 4 weeks
description: Serum concentration of procalcytonin (ng/mL)
measure: Change in bilirubin concentration
time frame: 4 weeks
description: Serum concentration of bilirubin (umol/L)
measure: Change in SGPT concentration
time frame: 4 weeks
description: Serum concentration of SGPT(U/l)
measure: Change in SGOT concentration
time frame: 4 weeks
description: Serum concentration of SGOT (U/l)
measure: Change in alkaline phosphatase concentration
time frame: 4 weeks
description: Serum concentration of alkaline phosphatase (U/l)
measure: Change in C-reactive protein concentration
time frame: 4 weeks
description: Serum concentration of CRP (mg/l)
arm group label: Inflammatory bowel disease
description: Patients with either Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19).
arm group label: Chronic intestinal failure
description: Patients with intestinal failure (CIF, n=20)
intervention type: Drug
intervention name: Omegaven
description: Pure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the additional product along with the standard lipid emulsion to reach a fish oil dose of approx. 0.5 g fish oil/kg/d.
arm group label: Chronic intestinal failure
arm group label: Inflammatory bowel disease
other name: Fish oil
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stanislaw Klek, PhD
role: Principal Investigator
affiliation: 1972
facility: 
country: Poland
citation: Klek S, Szczepanek K, Scislo L, Walewska E, Pietka M, Pisarska M, Pedziwiatr M. Intravenous lipid emulsions and liver function in adult chronic intestinal failure patients: results from a randomized clinical trial. Nutrition. 2018 Nov;55-56:45-50. doi: 10.1016/j.nut.2018.03.008. Epub 2018 Mar 22.
PMID: 29960156
responsible party type: Principal Investigator
investigator affiliation: Stanley Dudrick's Memorial Hospital
investigator full name: Stanislaw Klek
investigator title: Head of the Unit
mesh term: Metabolic Diseases
mesh term: Lipid Metabolism Disorders
mesh term: Inflammation
sharing ipd: No