<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/NCT03039257</url>
  </required_header>
  <id_info>
    <org_study_id>2016-5937</org_study_id>
    <nct_id>NCT03039257</nct_id>
  </id_info>
  <brief_title>Vitamin A Replacement in Patients Undergoing HSCT and Its Role on MBI-LCBI Rates</brief_title>
  <official_title>Single, High Dose Vitamin A Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation and Its Role on MBI-LCBI Rates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</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>
      The primary objective of this study is to establish that single dose vitamin A&#xD;
      supplementation is feasible and safe in pediatric and young adult bone marrow transplant&#xD;
      recipients until day +30 (± 7 days) after hematopoietic stem cell transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators' preliminary data suggest that low levels of vitamin A directly impact risk&#xD;
      of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI), likely via&#xD;
      decreased gut permeability, and they hypothesize supplemental vitamin A at the time of HSCT&#xD;
      can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). A&#xD;
      3x3 dose escalation/de-escalation study design will be used to determine the safety and&#xD;
      dosing required to maintain vitamin A levels in the upper quartile of normal range for age at&#xD;
      day +30 (± 7 days) with single dose vitamin A supplementation prior to hematopoietic stem&#xD;
      cell transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Actual">March 28, 2018</completion_date>
  <primary_completion_date type="Actual">January 17, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vitamin A Level</measure>
    <time_frame>30 days after HSCT</time_frame>
    <description>Vitamin A level will be measured 30 days after HSCT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI)</measure>
    <time_frame>100 days after HSCT</time_frame>
    <description>Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) 100 days after HSCT.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Hematopoietic Stem Cell Transplant</condition>
  <arm_group>
    <arm_group_label>Vitamin A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants receive single dose vitamin A supplementation prior to HSCT. A 3x3 dose escalation/de-escalation design will be used for this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin A</intervention_name>
    <description>Dose administration will start with 2500 IU/kg with maximum dose of 250,000 IU orally.</description>
    <arm_group_label>Vitamin A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient undergoing HSCT.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vitamin A hypersensitivity or allergy.&#xD;
&#xD;
          -  Age less than 1 year at time of transplant.&#xD;
&#xD;
          -  Baseline pre-HSCT vitamin A levels higher than the upper quartile of normal range for&#xD;
             age.&#xD;
&#xD;
          -  Enteral feeding or medication intolerance.&#xD;
&#xD;
          -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stella Davies, MBBS, PhD, MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>May 29, 2018</last_update_submitted>
  <last_update_submitted_qc>May 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hematopoietic stem cell transplant</keyword>
  <keyword>vitamin a</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin A</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/NCT03039257
org study id: 2016-5937
nct id: NCT03039257
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to establish that single dose vitamin A
      supplementation is feasible and safe in pediatric and young adult bone marrow transplant
      recipients until day +30 (± 7 days) after hematopoietic stem cell transplantation.
The investigators' preliminary data suggest that low levels of vitamin A directly impact risk
      of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI), likely via
      decreased gut permeability, and they hypothesize supplemental vitamin A at the time of HSCT
      can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). A
      3x3 dose escalation/de-escalation study design will be used to determine the safety and
      dosing required to maintain vitamin A levels in the upper quartile of normal range for age at
      day +30 (± 7 days) with single dose vitamin A supplementation prior to hematopoietic stem
      cell transplantation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Vitamin A Level
time frame: 30 days after HSCT
description: Vitamin A level will be measured 30 days after HSCT.
measure: Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI)
time frame: 100 days after HSCT
description: Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) 100 days after HSCT.
arm group label: Vitamin A
arm group type: Other
description: Participants receive single dose vitamin A supplementation prior to HSCT. A 3x3 dose escalation/de-escalation design will be used for this study.
intervention type: Dietary Supplement
intervention name: Vitamin A
description: Dose administration will start with 2500 IU/kg with maximum dose of 250,000 IU orally.
arm group label: Vitamin A
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
last name: Stella Davies, MBBS, PhD, MRCP
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vitamin A
sharing ipd: No