xml: <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/NCT06033105</url>
    </required_header>
    <id_info>
      <org_study_id>2191982</org_study_id>
      <nct_id>NCT06033105</nct_id>
    </id_info>
    <brief_title>Vitamin D Deficiency as a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus</brief_title>
    <official_title>Vitamin D Deficiency as a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus: a Case-control Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fayoum University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fayoum University</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>
        To investigate the role of Vitamin D (VD) deficiency as a risk factor for the development and&#xD;
        malignant transformation of Oral lichen planus (OLP) taking into consideration sex, dietary&#xD;
        habits, sun exposure, socioeconomic status and psychological factors.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Actual">August 24, 2023</completion_date>
    <primary_completion_date type="Actual">August 24, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>serum vitamin D level in OLP</measure>
      <time_frame>1 month</time_frame>
      <description>measured by ELISA</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>serum vitamin D level in correlation with sex, dietary habits and sun exposure.</measure>
      <time_frame>1 month</time_frame>
      <description>Questionnaire, measured in proportions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>serum vitamin D level in correlation with socioeconomic status</measure>
      <time_frame>1 month</time_frame>
      <description>Kuppuswamy's socioeconomic status scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>serum vitamin D level in correlation with Psychological factors</measure>
      <time_frame>1 month</time_frame>
      <description>Depression Anxiety and Stress Scale 21 (DASS-21)</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">70</enrollment>
    <condition>Oral Lichen Planus</condition>
    <condition>Vitamin D Deficiency</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <description>35 OLP patients</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <description>35 healthy controls.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ELISA</intervention_name>
      <description>Enzyme-linked immunosorbent assay (ELISA) was used following manufacturer's instructions. This test uses a competitive ELISA-based technique that was designed to quantitatively determine the concentration of 1,25-dihydroxyvitamin D3/D2 in human serum.</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        blood samples&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          patients presenting with a clinical picture and histological findings that confirm the&#xD;
          diagnosis of OLP (Group A) and age, sex, and dietary habits matched healthy controls (Group&#xD;
          B).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (Group A) patients presenting with a clinical picture and histological findings that&#xD;
               confirm the diagnosis of OLP&#xD;
  &#xD;
            -  (Group B) age, sex, and dietary habits matched healthy controls.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) subjects who have been receiving any kind of VD supplements, multivitamins, or any&#xD;
               drug that may affect VD measurements&#xD;
  &#xD;
            -  (2) patients with suspected restoration-related or smokeless tobacco-related lesions.&#xD;
  &#xD;
            -  (3) patients with any systemic medical condition or pregnant females.&#xD;
  &#xD;
            -  (4) patients with VD toxicity (VD≥100 ng/ml).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Fayoum University</name>
        <address>
          <city>Fayoum</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fayoum University</investigator_affiliation>
      <investigator_full_name>Salsabeel</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lichen Planus, Oral</mesh_term>
      <mesh_term>Lichen Planus</mesh_term>
      <mesh_term>Vitamin D Deficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Upon Request</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033105
  org study id: 2191982
  nct id: NCT06033105
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To investigate the role of Vitamin D (VD) deficiency as a risk factor for the development and
        malignant transformation of Oral lichen planus (OLP) taking into consideration sex, dietary
        habits, sun exposure, socioeconomic status and psychological factors.
  observational model: Case-Control
  time perspective: Prospective
  measure: serum vitamin D level in OLP
  time frame: 1 month
  description: measured by ELISA
  measure: serum vitamin D level in correlation with sex, dietary habits and sun exposure.
  time frame: 1 month
  description: Questionnaire, measured in proportions
  measure: serum vitamin D level in correlation with socioeconomic status
  time frame: 1 month
  description: Kuppuswamy's socioeconomic status scale
  measure: serum vitamin D level in correlation with Psychological factors
  time frame: 1 month
  description: Depression Anxiety and Stress Scale 21 (DASS-21)
  arm group label: Group A
  description: 35 OLP patients
  arm group label: Group B
  description: 35 healthy controls.
  intervention type: Device
  intervention name: ELISA
  description: Enzyme-linked immunosorbent assay (ELISA) was used following manufacturer's instructions. This test uses a competitive ELISA-based technique that was designed to quantitatively determine the concentration of 1,25-dihydroxyvitamin D3/D2 in human serum.
  arm group label: Group A
  arm group label: Group B
  blood samples
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Fayoum University
  investigator full name: Salsabeel
  investigator title: Lecturer
  mesh term: Lichen Planus, Oral
  mesh term: Lichen Planus
  mesh term: Vitamin D Deficiency
  sharing ipd: Undecided
  ipd description: Upon Request