<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/NCT04404842</url>
  </required_header>
  <id_info>
    <org_study_id>14052020</org_study_id>
    <nct_id>NCT04404842</nct_id>
  </id_info>
  <brief_title>Development of a Screening Tool for the Risk of Vitamin D Deficiency</brief_title>
  <acronym>EvidenceQ</acronym>
  <official_title>Development of a Screening Tool for the Risk of Vitamin D Deficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pavia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Istituti Clinici Scientifici Maugeri SpA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pavia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since vitamin D deficiency is a condition that affects a high percentage of individuals of&#xD;
      all ages and given the attention on the possible role of the deficiency of this vitamin in&#xD;
      the development of various chronic diseases, including cardiovascular and metabolic disease&#xD;
      (obesity, insulin resistance, hypertension, diabetes) and the correlation with mortality from&#xD;
      major cardiovascular events (heart failure, myocardial infarction, sudden cardiac death,&#xD;
      stroke, atrial fibrillation and peripheral vascular disease), it is clear that in clinical&#xD;
      practice it is necessary to provide screening tools characterized by a simple use, high&#xD;
      efficacy and a low economic impact, useful to detect a possible deficiency state that has a&#xD;
      significant impact on general health and therefore provide targeted interventions for&#xD;
      diagnosis and supplementation when and if necessary. Therefore, the objective of this study&#xD;
      project is part of the broader context of supporting, with reproducible and shared scientific&#xD;
      data, operational protocols useful for the clinician to identify subjects potentially at risk&#xD;
      of vitamin D deficiency as well as directing to the diagnostic and more effective&#xD;
      therapeutic. Surveillance of vitamin D status should be a high priority in which easy-to-use&#xD;
      and interpreted tools, such as the questionnaire developed for this study, could respond to&#xD;
      the needs of early identification of subjects potentially at risk of hypovitaminosis D, thus&#xD;
      supporting the work of the clinician.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It will be administered the questionnaire which includes specific and previously identified&#xD;
      questions useful for the purpose of the study to all patients who belong to the clinic of the&#xD;
      Dietetics and Clinical Nutrition, Internal Medicine and Endocrinology Unit, ICS Maugeri di&#xD;
      Pavia who meet the inclusion criteria and signed the Informed Consent. The blood dosage of 25&#xD;
      (OH) D will be used as a reference standard useful for achieving the purpose of the study&#xD;
      subject to the execution of diagnostic-therapeutic procedures that are beneficial to the&#xD;
      patient or performed for routine diagnostic procedures or previously prescribed by the&#xD;
      general practitioner. The collected data will be entered in the Data Collected Form together&#xD;
      with the laboratory tests.&#xD;
&#xD;
      Therefore, all patients will receive the EVIDENCE Questionnaire which includes 19 items that&#xD;
      investigate those factors that influence the production, absorption and intake of vitamin D:&#xD;
&#xD;
        -  anthropometric data (weight, height, waist circumference, BMI),&#xD;
&#xD;
        -  demographic information, such as latitude and phototype,&#xD;
&#xD;
        -  dietary intake of vitamin D,&#xD;
&#xD;
        -  health status and therapies,&#xD;
&#xD;
        -  multivitamin or vitamin D supplementation,&#xD;
&#xD;
        -  sun exposure habits according to the season, frequency and time of exposure, the body&#xD;
           parts exposed, the sunscreens use and outdoor activities.&#xD;
&#xD;
      The aim of the study is to develop a questionnaire useful in screening the adequacy of&#xD;
      vitamin D concentration in the adult population and to produce evidence of construct validity&#xD;
      and concurrent validity of the questionnaire itself.&#xD;
&#xD;
      SAMPLE SIZE: Psychometric literature suggests enrolling around 5-10 subjects for each item.&#xD;
      Considering the number of items in the questionnaire, equal to 19, the number of subjects to&#xD;
      be enrolled will be approximately 190.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 14, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Construct validity (EVIDENCE Questionnaire)</measure>
    <time_frame>1 hour</time_frame>
    <description>The construct validity of the questionnaire will be assessed using exploratory factorial analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Internal consistency (EVIDENCE Questionnaire)</measure>
    <time_frame>1 hour</time_frame>
    <description>The internal consistency will be evaluated with the Cronbach alpha coefficient or with the McDonald Omega coefficient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concurrent validity (EVIDENCE Questionnaire)</measure>
    <time_frame>1 hour</time_frame>
    <description>The concurrent validity will be assessed by comparing the results obtained with the serum 25 (OH) D dosage taken as the reference standard.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Questionnaire Scoring</measure>
    <time_frame>1 hour</time_frame>
    <description>Determine the optimal cut-off score of EvidenceQ for screening of subjects potentially at risk of vitamin D inadequacy.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <condition>Vitamin D3 Deficiency</condition>
  <condition>Vitamin D</condition>
  <arm_group>
    <arm_group_label>EvidenceQ Cohort</arm_group_label>
    <description>Adult subjects, aged over 18 years, male and female.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Psychometric literature suggests that about 5-10 subjects should be recruited for each item&#xD;
        (Steiner DL et al, 2015). Considering the number of items in the questionnaire, equal to&#xD;
        19, the number of subjects to enlist will be about 190.&#xD;
&#xD;
        Consecutively recruited adult patients by the Service of Dietetics and Clinical Nutrition,&#xD;
        Unit of Internal Medicine and Endocrinology, of both sexes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects older than or equal 18 years;&#xD;
&#xD;
          -  Absence of liver pathologies;&#xD;
&#xD;
          -  Absence of kidney pathologies;&#xD;
&#xD;
          -  Absence of intestinal malabsorption syndromes;&#xD;
&#xD;
          -  Absence of bariatric surgery;&#xD;
&#xD;
          -  Absence of cancer;&#xD;
&#xD;
          -  Absence of primary hyperparathyroidism;&#xD;
&#xD;
          -  Absence of extensive dermatological pathologies (e.g. psoriasis, atopic dermatitis,&#xD;
             vitiligo)&#xD;
&#xD;
          -  Absence of supplementation with multivitamin supplements or vitamin D;&#xD;
&#xD;
          -  Absence of chronic drug therapy with: anticonvulsants, antipsychotics,&#xD;
             glucocorticoids, immunosuppressive corticosteroids, anti-retrovirals, slimming,&#xD;
             hypocolestrolemicants, laxatives (prolonged use);&#xD;
&#xD;
          -  acceptance and sign of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects under 18 years old;&#xD;
&#xD;
          -  Affected by liver pathologies;&#xD;
&#xD;
          -  Affected by kidney pathologies;&#xD;
&#xD;
          -  Affected by intestinal malabsorption syndromes;&#xD;
&#xD;
          -  Affected by cancer;&#xD;
&#xD;
          -  Affected by primary hyperparathyroidism;&#xD;
&#xD;
          -  Affected by extensive dermatological pathologies (e.g. psoriasis, atopic dermatitis,&#xD;
             vitiligo).&#xD;
&#xD;
          -  Candidates and/or undergoing bariatric surgery;&#xD;
&#xD;
          -  Supplementation with multivitamin or vitamin D;&#xD;
&#xD;
          -  Chronic therapy with: anticonvulsants, antipsychotics, glucocorticoids,&#xD;
             immunosuppressive corticosteroids, anti-retrovirals, slimming, hypocolestrolemizzanti,&#xD;
             laxatives (prolonged use).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Hellas Cena</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univeristy of Pavia, ICS Maugeri SpA SB</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chiara Elena Tomasinelli</last_name>
    <phone>+39 0382 987536</phone>
    <email>chiara.tomasinelli@unipv.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hellas Cena</last_name>
    <phone>0382 987542</phone>
    <email>hellas.cena@unipv.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Istituti Clinici Scientifici Maugeri SpA</name>
      <address>
        <city>Pavia</city>
        <state>Lombardia</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hellas Cena</last_name>
      <phone>+39 0382 987542</phone>
      <email>hellas.cena@unipv.it</email>
    </contact>
    <investigator>
      <last_name>Chiara Elena Tomasinelli, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rachele De Giuseppe, Lecturer</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giorgia Preatoni, Student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pavia</investigator_affiliation>
    <investigator_full_name>Hellas Cena</investigator_full_name>
    <investigator_title>Tenured researcher</investigator_title>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <keyword>Cholecalciferol</keyword>
  <keyword>Deficiency</keyword>
  <keyword>Inadeguacy</keyword>
  <keyword>Screening</keyword>
  <keyword>Questionnaire</keyword>
  <keyword>Survey</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <!-- 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/NCT04404842
org study id: 14052020
nct id: NCT04404842
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Since vitamin D deficiency is a condition that affects a high percentage of individuals of
      all ages and given the attention on the possible role of the deficiency of this vitamin in
      the development of various chronic diseases, including cardiovascular and metabolic disease
      (obesity, insulin resistance, hypertension, diabetes) and the correlation with mortality from
      major cardiovascular events (heart failure, myocardial infarction, sudden cardiac death,
      stroke, atrial fibrillation and peripheral vascular disease), it is clear that in clinical
      practice it is necessary to provide screening tools characterized by a simple use, high
      efficacy and a low economic impact, useful to detect a possible deficiency state that has a
      significant impact on general health and therefore provide targeted interventions for
      diagnosis and supplementation when and if necessary. Therefore, the objective of this study
      project is part of the broader context of supporting, with reproducible and shared scientific
      data, operational protocols useful for the clinician to identify subjects potentially at risk
      of vitamin D deficiency as well as directing to the diagnostic and more effective
      therapeutic. Surveillance of vitamin D status should be a high priority in which easy-to-use
      and interpreted tools, such as the questionnaire developed for this study, could respond to
      the needs of early identification of subjects potentially at risk of hypovitaminosis D, thus
      supporting the work of the clinician.
It will be administered the questionnaire which includes specific and previously identified
      questions useful for the purpose of the study to all patients who belong to the clinic of the
      Dietetics and Clinical Nutrition, Internal Medicine and Endocrinology Unit, ICS Maugeri di
      Pavia who meet the inclusion criteria and signed the Informed Consent. The blood dosage of 25
      (OH) D will be used as a reference standard useful for achieving the purpose of the study
      subject to the execution of diagnostic-therapeutic procedures that are beneficial to the
      patient or performed for routine diagnostic procedures or previously prescribed by the
      general practitioner. The collected data will be entered in the Data Collected Form together
      with the laboratory tests.

      Therefore, all patients will receive the EVIDENCE Questionnaire which includes 19 items that
      investigate those factors that influence the production, absorption and intake of vitamin D:

        -  anthropometric data (weight, height, waist circumference, BMI),

        -  demographic information, such as latitude and phototype,

        -  dietary intake of vitamin D,

        -  health status and therapies,

        -  multivitamin or vitamin D supplementation,

        -  sun exposure habits according to the season, frequency and time of exposure, the body
           parts exposed, the sunscreens use and outdoor activities.

      The aim of the study is to develop a questionnaire useful in screening the adequacy of
      vitamin D concentration in the adult population and to produce evidence of construct validity
      and concurrent validity of the questionnaire itself.

      SAMPLE SIZE: Psychometric literature suggests enrolling around 5-10 subjects for each item.
      Considering the number of items in the questionnaire, equal to 19, the number of subjects to
      be enrolled will be approximately 190.
observational model: Cohort
time perspective: Cross-Sectional
measure: Construct validity (EVIDENCE Questionnaire)
time frame: 1 hour
description: The construct validity of the questionnaire will be assessed using exploratory factorial analysis.
measure: Internal consistency (EVIDENCE Questionnaire)
time frame: 1 hour
description: The internal consistency will be evaluated with the Cronbach alpha coefficient or with the McDonald Omega coefficient.
measure: Concurrent validity (EVIDENCE Questionnaire)
time frame: 1 hour
description: The concurrent validity will be assessed by comparing the results obtained with the serum 25 (OH) D dosage taken as the reference standard.
measure: Questionnaire Scoring
time frame: 1 hour
description: Determine the optimal cut-off score of EvidenceQ for screening of subjects potentially at risk of vitamin D inadequacy.
arm group label: EvidenceQ Cohort
description: Adult subjects, aged over 18 years, male and female.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Hellas Cena
role: Principal Investigator
affiliation: Univeristy of Pavia, ICS Maugeri SpA SB
last name: Chiara Elena Tomasinelli
phone: +39 0382 987536
email: chiara.tomasinelli@unipv.it
last name: Hellas Cena
phone: 0382 987542
email: hellas.cena@unipv.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Pavia
investigator full name: Hellas Cena
investigator title: Tenured researcher
mesh term: Vitamin D Deficiency