<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/NCT02199821</url>
  </required_header>
  <id_info>
    <org_study_id>PI-00000</org_study_id>
    <nct_id>NCT02199821</nct_id>
  </id_info>
  <brief_title>Inflammatory Response With Different Lipid Emulsions In Parenteral Nutrition In Children After Bone Marrow Transplantation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maimónides Biomedical Research Institute of Córdoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maimónides Biomedical Research Institute of Córdoba</source>
  <brief_summary>
    <textblock>
      Background and Aims: Nutritional support is considered an integral part of the supportive&#xD;
      care of bone marrow transplantation patients. Parenteral nutrition emulsions enriched with&#xD;
      omega-3 fatty acids can modify the inflammatory response. The aim of this study is to compare&#xD;
      plasma cytokines levels in children after bone marrow transplantation using a lipid formula&#xD;
      enriched in n-3 FA and other classic soybean oil formula in parenteral nutrition.&#xD;
&#xD;
      Methods: A randomized double blinded controlled study including 14 children with BMT and&#xD;
      requiring PN for at least 10 days was conducted using a lipid emulsion with fish oil, or&#xD;
      soybean oil. Blood samples at baseline, at 10 days and at the end of the PN were taken to&#xD;
      analyze plasma interleukins 1 beta, 2, 6, 8, 10 (IL-10) and tumor necrosis factor alpha&#xD;
      (TNF-α).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>average cytokines plasma levels between groups of children with the two different lipid formulas.</measure>
    <time_frame>21 days</time_frame>
    <description>The primary outcome of the trial was average cytokines plasma levels between groups of children with the two different lipid formulas.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anthropometric measurements such as: weight height</measure>
    <time_frame>21 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse effects associated with formula consumption.</measure>
    <time_frame>21 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Bone Narrow Transplantation</condition>
  <arm_group>
    <arm_group_label>Soybean oil formula commonly used in the hospita</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Formula with soybean oil, medium-chain triglyce</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Formula with soybean oil, medium-chain triglycerides</intervention_name>
    <arm_group_label>Formula with soybean oil, medium-chain triglyce</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Soybean oil formula commonly used in the hospital</intervention_name>
    <arm_group_label>Soybean oil formula commonly used in the hospita</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Term infants. Children with a stable medical condition. Children in need of parenteral&#xD;
        nutrition for at least 10 days, except for the cardiac group would be at least 5 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Premature infants Children over 14 years Children with hypersensitivity to egg ingestion or&#xD;
        soy protein Children with severe insufficiency of an organ, Children with inborn error of&#xD;
        metabolism, and any condition that does not allow random use of lipid emulsion type.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>April 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02199821
org study id: PI-00000
nct id: NCT02199821
lead sponsor: 
Background and Aims: Nutritional support is considered an integral part of the supportive
      care of bone marrow transplantation patients. Parenteral nutrition emulsions enriched with
      omega-3 fatty acids can modify the inflammatory response. The aim of this study is to compare
      plasma cytokines levels in children after bone marrow transplantation using a lipid formula
      enriched in n-3 FA and other classic soybean oil formula in parenteral nutrition.

      Methods: A randomized double blinded controlled study including 14 children with BMT and
      requiring PN for at least 10 days was conducted using a lipid emulsion with fish oil, or
      soybean oil. Blood samples at baseline, at 10 days and at the end of the PN were taken to
      analyze plasma interleukins 1 beta, 2, 6, 8, 10 (IL-10) and tumor necrosis factor alpha
      (TNF-α).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: average cytokines plasma levels between groups of children with the two different lipid formulas.
time frame: 21 days
description: The primary outcome of the trial was average cytokines plasma levels between groups of children with the two different lipid formulas.
measure: Anthropometric measurements such as: weight height
time frame: 21 days
measure: Incidence of adverse effects associated with formula consumption.
time frame: 21 days
arm group label: Soybean oil formula commonly used in the hospita
arm group type: Active Comparator
arm group label: Formula with soybean oil, medium-chain triglyce
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Formula with soybean oil, medium-chain triglycerides
arm group label: Formula with soybean oil, medium-chain triglyce
intervention type: Dietary Supplement
intervention name: Soybean oil formula commonly used in the hospital
arm group label: Soybean oil formula commonly used in the hospita
criteria: 
gender: All
minimum age: 1 Day
maximum age: 14 Years
healthy volunteers: No
responsible party type: Sponsor