<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/NCT03818594</url>
  </required_header>
  <id_info>
    <org_study_id>VITAD-01-2018 Part 1</org_study_id>
    <nct_id>NCT03818594</nct_id>
  </id_info>
  <brief_title>Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 1</brief_title>
  <acronym>VITAD/1</acronym>
  <official_title>Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nutrition Institute, Slovenia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VIST - Faculty of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Slovenian Research Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Valens Int. d.o.o., Slovenija</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nutrition Institute, Slovenia</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>
      Seasonal variations in vitamin D status will be determined on a cohort of Slovenian adults&#xD;
      using longitudinal study design, and association between vitamin D status and different&#xD;
      Caucasian phototypes, skin colour and melanin index investigated .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">September 28, 2020</completion_date>
  <primary_completion_date type="Actual">September 28, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between vitamin D serum levels in winter and in summer season will be determined</measure>
    <time_frame>2 years</time_frame>
    <description>Vitamin D serum level will be measured once in winter (December - January) and once in summer season (August-September) for each individual. The study will be performed over two consecutive years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of vitamin D serum levels with Fitzpatrick skin phototype</measure>
    <time_frame>2 years</time_frame>
    <description>Fitzpatrick skin phototype will be determined using Fitzpatrick self-evaluation questionnaire in combination with expert assessment in August-September.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of vitamin D serum levels with skin colour measured in CIE Lab colour space</measure>
    <time_frame>2 years</time_frame>
    <description>Skin colour will be measured in CIE Lab colour space on inner and outer side of the upper arm. The measurement will be performed in August-September.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of vitamin D serum levels with melanin index</measure>
    <time_frame>2 years</time_frame>
    <description>Melanin index will be measured on inner and outer side of the upper arm. The measurement will be performed in August-September.</description>
  </secondary_outcome>
  <enrollment type="Actual">338</enrollment>
  <condition>Vitamin D Serum Levels</condition>
  <eligibility>
    <study_pop>
      <textblock>
        General Slovenian adult population, men and women, skin phototypes I-IV.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed Informed consent form (ICF),&#xD;
&#xD;
          -  Caucasian race&#xD;
&#xD;
          -  Age between 18 and 65 years at the time of the signature of Informed consent form&#xD;
             (ICF),&#xD;
&#xD;
          -  Willingness to avoid a consumption of any food supplements containing Vitamin D during&#xD;
             the study, except the ones prescribed by the study researchers, and to avoid use of&#xD;
             solarium or other artificial UVB sources&#xD;
&#xD;
          -  Willingness to follow all study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breastfeeding,&#xD;
&#xD;
          -  Known or suspected allergy to any ingredient of the tested products in Part 2,&#xD;
&#xD;
          -  Pronounced avoidance of sunshine (eg reporting of allergy to the sun)&#xD;
&#xD;
          -  Use of food supplements containing Vitamin D or fish oil or omega 3 fatty acids in&#xD;
             last three months prior to inclusion,&#xD;
&#xD;
          -  Special dietary habits used by a small part of the population (veganism, low-carb&#xD;
             hihg-fat diet, caloric restriction diet, note: vegetarians are not excluded)&#xD;
&#xD;
          -  Diets prescribed by the medical profession&#xD;
&#xD;
          -  Disorders of the kidneys, thyroid, digestive tract, osteoporosis and other bone&#xD;
             diseases, skin diseases&#xD;
&#xD;
          -  Other diseases and conditions that affect the absorption and synthesis of vitamin D&#xD;
&#xD;
          -  Exposure to stronger sunlight in the last three months prior to engaging in a survey&#xD;
             (travel to countries with stronger sunshine, use of solarium),&#xD;
&#xD;
          -  The consumption of margarine or plant substitutes for milk / milk products several&#xD;
             times a day, as these foods are most often enriched with vitamin D,&#xD;
&#xD;
          -  Visiting the solarium in the last three months before joining the survey,&#xD;
&#xD;
          -  Mental incapacity that precludes adequate understanding or cooperation.&#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>Katja Žmitek, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Researcher</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nutrition Institute, Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>June 16, 2021</last_update_submitted>
  <last_update_submitted_qc>June 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03818594
org study id: VITAD-01-2018 Part 1
nct id: NCT03818594
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Seasonal variations in vitamin D status will be determined on a cohort of Slovenian adults
      using longitudinal study design, and association between vitamin D status and different
      Caucasian phototypes, skin colour and melanin index investigated .
observational model: Cohort
time perspective: Prospective
measure: Difference between vitamin D serum levels in winter and in summer season will be determined
time frame: 2 years
description: Vitamin D serum level will be measured once in winter (December - January) and once in summer season (August-September) for each individual. The study will be performed over two consecutive years.
measure: Correlation of vitamin D serum levels with Fitzpatrick skin phototype
time frame: 2 years
description: Fitzpatrick skin phototype will be determined using Fitzpatrick self-evaluation questionnaire in combination with expert assessment in August-September.
measure: Correlation of vitamin D serum levels with skin colour measured in CIE Lab colour space
time frame: 2 years
description: Skin colour will be measured in CIE Lab colour space on inner and outer side of the upper arm. The measurement will be performed in August-September.
measure: Correlation of vitamin D serum levels with melanin index
time frame: 2 years
description: Melanin index will be measured on inner and outer side of the upper arm. The measurement will be performed in August-September.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Katja Žmitek, PhD
role: Principal Investigator
affiliation: Researcher
facility: 
country: Slovenia
responsible party type: Sponsor
sharing ipd: No