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/NCT05997199</url>
    </required_header>
    <id_info>
      <org_study_id>B.10.1.THK.4.34.H.GP.0.01/76</org_study_id>
      <nct_id>NCT05997199</nct_id>
    </id_info>
    <brief_title>The Effect Vitamin D on the Recovery Rate of Bell Palsy</brief_title>
    <official_title>The Effect of Serum Vitamin D on the Recovery Rate of Bell Palsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Umraniye Education and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Umraniye Education and Research 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>
        Patients aged between 18-65 who visit the Physical Medicine and Rehabilitation outpatient&#xD;
        clinic diagnosed with Bell Palsy will be included in the study. The patients' Bell Palsy&#xD;
        grade will be evaluated by Houseman Brahman (HB) Scale and their disability level will be&#xD;
        evaluated by Facial Disability Index (FDI). Their serum vitamin D level will be noted. The&#xD;
        patients having vitamin D deficiency will be randomized into two groups. Group 1 will be&#xD;
        given 50.000 IU/week vitamin D replacement for 8 weeks. All the patients will be included in&#xD;
        a standard physical therapy and home exercise program. Both groups will be asked for a&#xD;
        control visit at weeks 8.Their clinical recovery will be evaluated by HB staging and FDI by&#xD;
        the Physical Medicine and Rehabilitation specialist who is blind to the randomization.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients aged between 18-65 who visit the Physical Medicine and Rehabilitation outpatient&#xD;
        clinic diagnosed with Bell Palsy will be included in the study. Facial palsy stages of&#xD;
        patients will be graded from 1 to 6 according to the Houseman Brahman (HB) staging system. In&#xD;
        order to determine the disability criteria of the patients, a form called Facial Disability&#xD;
        Index (FDI)-Facial Disability Index will be filled. This scale consists of 10 questions and&#xD;
        is a validated test evaluating the physical and social function of the patient. The patients&#xD;
        having vitamin D deficiency will be randomized into two groups. One group will be getting a&#xD;
        vitamin d replacement treatment for 8 weeks. A physical therapy program in the form of a&#xD;
        standard exercise program including electrical stimulation and facial paralysis exercises&#xD;
        will be organized for all the patients. The patients will be evaluated at 8th week by HB and&#xD;
        FDI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 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>Houseman Brahman (HB) Level</measure>
      <time_frame>HB stages of the patients will be recorded at week 8.</time_frame>
      <description>Facial palsy stages of patients will be graded from 1 to 6 according to the Houseman Brahman (HB) staging system. Grade 1 refers to normal facial nerve function whereas 6 refer to complete paralysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Facial Disability Index (FDI)</measure>
      <time_frame>FDI of the patients will be recorded at week 8.</time_frame>
      <description>This scale consists of 10 questions and is a validated test evaluating the physical and social function of the patient. It is scored out of 100. Higher score is the best result.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Bell Palsy</condition>
    <condition>Vitamin D Deficiency</condition>
    <condition>Facial Paralysis</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <description>Patients with vitamin D deficiency and having Vitamin D Replacement</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <description>Control Group. Patients with vitamin D deficiency but not getting Vitamin D replacement</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Vitamin D replacement</intervention_name>
      <description>Group 1 with vitamin D deficiency will be getting a standart vitamin D replacement of 50.000 IU/week for 8 weeks.</description>
      <arm_group_label>Group 1</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients Diagnosed with Bell palsy and treated with standard medical treatment in the last&#xD;
          3 weeks&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being cooperative-orientated&#xD;
  &#xD;
            -  Willing to participate in the Physical Therapy home exercise program&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being Non cooperative, disorientated&#xD;
  &#xD;
            -  Failure to comply with the Physical Therapy home exercise program&#xD;
  &#xD;
            -  History of malignancy&#xD;
  &#xD;
            -  Additional neurological disease&#xD;
  &#xD;
            -  Having cranial pathologies&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Özlem Kaleoğlu, M.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Umraniye Education and Research Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Özlem Kaleoğlu</name>
        <address>
          <city>Istanbul</city>
          <state>Üsküdar</state>
          <zip>34000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
      <investigator_full_name>Özlem Kaleoğlu Aslan</investigator_full_name>
      <investigator_title>Principle Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bell Palsy</mesh_term>
      <mesh_term>Facial Paralysis</mesh_term>
      <mesh_term>Paralysis</mesh_term>
      <mesh_term>Vitamin D Deficiency</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitamin D</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05997199
  org study id: B.10.1.THK.4.34.H.GP.0.01/76
  nct id: NCT05997199
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients aged between 18-65 who visit the Physical Medicine and Rehabilitation outpatient
        clinic diagnosed with Bell Palsy will be included in the study. The patients' Bell Palsy
        grade will be evaluated by Houseman Brahman (HB) Scale and their disability level will be
        evaluated by Facial Disability Index (FDI). Their serum vitamin D level will be noted. The
        patients having vitamin D deficiency will be randomized into two groups. Group 1 will be
        given 50.000 IU/week vitamin D replacement for 8 weeks. All the patients will be included in
        a standard physical therapy and home exercise program. Both groups will be asked for a
        control visit at weeks 8.Their clinical recovery will be evaluated by HB staging and FDI by
        the Physical Medicine and Rehabilitation specialist who is blind to the randomization.
  Patients aged between 18-65 who visit the Physical Medicine and Rehabilitation outpatient
        clinic diagnosed with Bell Palsy will be included in the study. Facial palsy stages of
        patients will be graded from 1 to 6 according to the Houseman Brahman (HB) staging system. In
        order to determine the disability criteria of the patients, a form called Facial Disability
        Index (FDI)-Facial Disability Index will be filled. This scale consists of 10 questions and
        is a validated test evaluating the physical and social function of the patient. The patients
        having vitamin D deficiency will be randomized into two groups. One group will be getting a
        vitamin d replacement treatment for 8 weeks. A physical therapy program in the form of a
        standard exercise program including electrical stimulation and facial paralysis exercises
        will be organized for all the patients. The patients will be evaluated at 8th week by HB and
        FDI.
  observational model: Case-Control
  time perspective: Prospective
  measure: Houseman Brahman (HB) Level
  time frame: HB stages of the patients will be recorded at week 8.
  description: Facial palsy stages of patients will be graded from 1 to 6 according to the Houseman Brahman (HB) staging system. Grade 1 refers to normal facial nerve function whereas 6 refer to complete paralysis.
  measure: Facial Disability Index (FDI)
  time frame: FDI of the patients will be recorded at week 8.
  description: This scale consists of 10 questions and is a validated test evaluating the physical and social function of the patient. It is scored out of 100. Higher score is the best result.
  arm group label: Group 1
  description: Patients with vitamin D deficiency and having Vitamin D Replacement
  arm group label: Group 2
  description: Control Group. Patients with vitamin D deficiency but not getting Vitamin D replacement
  intervention type: Dietary Supplement
  intervention name: Vitamin D replacement
  description: Group 1 with vitamin D deficiency will be getting a standart vitamin D replacement of 50.000 IU/week for 8 weeks.
  arm group label: Group 1
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Özlem Kaleoğlu, M.D
  role: Principal Investigator
  affiliation: Umraniye Education and Research Hospital
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Umraniye Education and Research Hospital
  investigator full name: Özlem Kaleoğlu Aslan
  investigator title: Principle Investigator
  mesh term: Bell Palsy
  mesh term: Facial Paralysis
  mesh term: Paralysis
  mesh term: Vitamin D Deficiency
  mesh term: Vitamin D
  sharing ipd: No