<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/NCT03246308</url>
  </required_header>
  <id_info>
    <org_study_id>1462/2017</org_study_id>
    <nct_id>NCT03246308</nct_id>
  </id_info>
  <brief_title>Investigation of Vitamin Levels During Phototherapy</brief_title>
  <official_title>Investigation of Vitamin Levels During Phototherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      Research project in which blood samples of patients undergoing UVB phototherapy for the&#xD;
      treatment of different cutaneous diseases will be investigated for changes of folate levels&#xD;
      and further vitamins over the course of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      UVB phototherapy is used to treat a plethora of different dermatoses with a favorable side&#xD;
      effect profile compared to systemic alternatives. One rarely mentioned issue related to&#xD;
      phototherapy is the question of whether it holds potential to decrease folate serum levels,&#xD;
      which is of particular interest to women of childbearing age, as birth defects, such as&#xD;
      neural tube defects (NTD), cardiac defects, and facial clefting have all been noted to be&#xD;
      increased in women with folate deficiency. Several studies, involving different patient&#xD;
      groups and modes of phototherapy, have investigated the changes of folate levels throughout&#xD;
      therapy showing mixed results. While two small open studies from Egypt showed a significant&#xD;
      reduction of folate levels after 24 and 18 / 36 exposures (1-2), several other studies failed&#xD;
      to show a significant change (3-6). In addition, there are also conflicting data on the&#xD;
      influence of UVB phototherapy on vitamin D, vitamin B12 and homocysteine levels. Therefore,&#xD;
      the presented prospective trial aims at investigating the changes of these vitamins during a&#xD;
      routine course of phototherapy. The study will focus on the following specific aims: Measure&#xD;
      the levels of folate as well as the levels of further vitamin parameters (including&#xD;
      homocysteine, 25-OH-vitamin D3, 1,25-OH-vitamin D3, holotranscobalamin and methylmalonic&#xD;
      acid) before and during phototherapy (at baseline, after 12, 24 and 36 exposures and/or at&#xD;
      the end of treatment)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Folate level</measure>
    <time_frame>3 years</time_frame>
    <description>The change of the folate levels will be measured at baseline and at the end of phototherapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>vitamin D level</measure>
    <time_frame>3 years</time_frame>
    <description>The change of vitamin D levels will be measured at baseline and at the end of phototherapy.</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Phototherapy Complication</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Phototherapy</intervention_name>
    <description>Taking blood sample.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing UVB therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing UVB phototherapy (narrowband UVB or broadband UVB)&#xD;
&#xD;
          -  Male and female participants minimum 18 years old&#xD;
&#xD;
          -  Written informed consent by the participant after information about the research&#xD;
             project&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular sunbed use&#xD;
&#xD;
          -  Underlying disease with abnormal folate metabolism (e.g. thalassemia)&#xD;
&#xD;
          -  Age below 18 years&#xD;
&#xD;
          -  Patients who will not be able to attend regularly for treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>May 1, 2019</last_update_submitted>
  <last_update_submitted_qc>May 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Benedikt Weber</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <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/NCT03246308
org study id: 1462/2017
nct id: NCT03246308
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Research project in which blood samples of patients undergoing UVB phototherapy for the
      treatment of different cutaneous diseases will be investigated for changes of folate levels
      and further vitamins over the course of treatment.
UVB phototherapy is used to treat a plethora of different dermatoses with a favorable side
      effect profile compared to systemic alternatives. One rarely mentioned issue related to
      phototherapy is the question of whether it holds potential to decrease folate serum levels,
      which is of particular interest to women of childbearing age, as birth defects, such as
      neural tube defects (NTD), cardiac defects, and facial clefting have all been noted to be
      increased in women with folate deficiency. Several studies, involving different patient
      groups and modes of phototherapy, have investigated the changes of folate levels throughout
      therapy showing mixed results. While two small open studies from Egypt showed a significant
      reduction of folate levels after 24 and 18 / 36 exposures (1-2), several other studies failed
      to show a significant change (3-6). In addition, there are also conflicting data on the
      influence of UVB phototherapy on vitamin D, vitamin B12 and homocysteine levels. Therefore,
      the presented prospective trial aims at investigating the changes of these vitamins during a
      routine course of phototherapy. The study will focus on the following specific aims: Measure
      the levels of folate as well as the levels of further vitamin parameters (including
      homocysteine, 25-OH-vitamin D3, 1,25-OH-vitamin D3, holotranscobalamin and methylmalonic
      acid) before and during phototherapy (at baseline, after 12, 24 and 36 exposures and/or at
      the end of treatment)
observational model: Other
time perspective: Prospective
measure: Folate level
time frame: 3 years
description: The change of the folate levels will be measured at baseline and at the end of phototherapy.
measure: vitamin D level
time frame: 3 years
description: The change of vitamin D levels will be measured at baseline and at the end of phototherapy.
intervention type: Radiation
intervention name: Phototherapy
description: Taking blood sample.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Benedikt Weber
investigator title: MD PhD
sharing ipd: No