<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/NCT03284840</url>
  </required_header>
  <id_info>
    <org_study_id>KME72/07/16</org_study_id>
    <nct_id>NCT03284840</nct_id>
  </id_info>
  <brief_title>Adults Nutrition as a Protective or Health-risk Factor</brief_title>
  <acronym>NUTRIHEALTH</acronym>
  <official_title>NUTRIHEALTH - Adults Nutrition as a Protective or Health-risk Factor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nutrition Institute, Slovenia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Public Health, Slovenia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Medical Centre Ljubljana</agency>
      <agency_class>Other</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>
      To obtain up-to-date data on nutrient intakes in adults, a national dietary survey - the EU&#xD;
      Menu study will be conducted during 12 consecutive months in 2017/2018, providing data on the&#xD;
      consumption of foods and enabling the assessment of energy and macronutrient intakes.&#xD;
      Participating subjects will be invited to NUTRIHEALTH study for assessment for micronutrient&#xD;
      status (focusing into vitamin D, folic acid, vitamin B12, and iron) and medical examination,&#xD;
      in which thyroid size will be aslo measured, to investigated thyroid epidemiology in&#xD;
      Slovenia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">September 13, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of inadequate vitamin D status</measure>
    <time_frame>1 year</time_frame>
    <description>epidemiology of vitamin D status will be investigated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of thyroid health</measure>
    <time_frame>1 year</time_frame>
    <description>epidemiology of thyroid Health will be investigated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of inadequate vitamin B12 status</measure>
    <time_frame>1 years</time_frame>
    <description>epidemiology of vitamin 12 status will be investigated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of inadequate folic acid status</measure>
    <time_frame>1 years</time_frame>
    <description>epidemiology of folic acid status will be investigated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of inadequate iron status</measure>
    <time_frame>1 years</time_frame>
    <description>epidemiology of iron status will be investigated</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">280</enrollment>
  <condition>Nutritional Status</condition>
  <condition>Nutrient Deficiency</condition>
  <condition>Micronutrient Deficiency</condition>
  <condition>Vitamin D Deficiency</condition>
  <condition>Vitamin B 12 Deficiency</condition>
  <condition>Folic Acid Deficiency</condition>
  <condition>Iron-deficiency</condition>
  <condition>Thyroid Diseases</condition>
  <condition>Diet</condition>
  <arm_group>
    <arm_group_label>Adults (18-65 years)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Elderly (65-74 years)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Assessement of nutritional status</intervention_name>
    <description>Nutritional status for vitamin D, folic acid, vitamin B12 and iron.</description>
    <arm_group_label>Adults (18-65 years)</arm_group_label>
    <arm_group_label>Elderly (65-74 years)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Thyroid size</intervention_name>
    <description>Thyroid size by ultrasound.</description>
    <arm_group_label>Adults (18-65 years)</arm_group_label>
    <arm_group_label>Elderly (65-74 years)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples will be freezed for possible further analyses on markers related with nutrition&#xD;
      &amp; health&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This observational study is conducted on randomly selected residents of Republic of&#xD;
        Slovenia. The EU Menu study (LOT2) include a minimum of 1.133 of habitants from Slovenia in&#xD;
        the age 18-74 years. In line with the EU Menu methodology and to ensure representativeness&#xD;
        of the sample, participants will be randomly selected from the Slovenian population using&#xD;
        Central Population Register (selection outsourced by the Statistical Office of Republic of&#xD;
        Slovenia ), and visited on their home. After completion of the EU Menu Survey&#xD;
        (questionnaires on self-reported health status and food intake), participants will be&#xD;
        invited to collaborate in the proposed study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resident of Republic of Slovenia (included to the register of residents)&#xD;
&#xD;
          -  Finished EU MENU Slovenia Study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not willing to give blood&amp;urine sample&#xD;
&#xD;
          -  Long-term disease&#xD;
&#xD;
          -  Living in institutions with controled diet, such as such as in elderly care, hospital,&#xD;
             prison, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Igor Pravst, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Nutrition Institute, Ljubljana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Public Health, Slovenia</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nutrition Institute, Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dietary intake</keyword>
  <keyword>nutritional status</keyword>
  <keyword>micronutrients</keyword>
  <keyword>thyroid health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
    <mesh_term>Vitamin B 12 Deficiency</mesh_term>
    <mesh_term>Folic Acid Deficiency</mesh_term>
    <mesh_term>Thyroid Diseases</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/NCT03284840
org study id: KME72/07/16
nct id: NCT03284840
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To obtain up-to-date data on nutrient intakes in adults, a national dietary survey - the EU
      Menu study will be conducted during 12 consecutive months in 2017/2018, providing data on the
      consumption of foods and enabling the assessment of energy and macronutrient intakes.
      Participating subjects will be invited to NUTRIHEALTH study for assessment for micronutrient
      status (focusing into vitamin D, folic acid, vitamin B12, and iron) and medical examination,
      in which thyroid size will be aslo measured, to investigated thyroid epidemiology in
      Slovenia.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Assessment of inadequate vitamin D status
time frame: 1 year
description: epidemiology of vitamin D status will be investigated
measure: Assessment of thyroid health
time frame: 1 year
description: epidemiology of thyroid Health will be investigated
measure: Assessment of inadequate vitamin B12 status
time frame: 1 years
description: epidemiology of vitamin 12 status will be investigated
measure: Assessment of inadequate folic acid status
time frame: 1 years
description: epidemiology of folic acid status will be investigated
measure: Assessment of inadequate iron status
time frame: 1 years
description: epidemiology of iron status will be investigated
arm group label: Adults (18-65 years)
arm group label: Elderly (65-74 years)
intervention type: Diagnostic Test
intervention name: Assessement of nutritional status
description: Nutritional status for vitamin D, folic acid, vitamin B12 and iron.
arm group label: Adults (18-65 years)
arm group label: Elderly (65-74 years)
intervention type: Diagnostic Test
intervention name: Thyroid size
description: Thyroid size by ultrasound.
arm group label: Adults (18-65 years)
arm group label: Elderly (65-74 years)
Blood samples will be freezed for possible further analyses on markers related with nutrition
      & health
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Igor Pravst, PhD
role: Study Chair
affiliation: Nutrition Institute, Ljubljana
facility: 
facility: 
facility: 
country: Slovenia
responsible party type: Sponsor
mesh term: Iron Deficiencies
mesh term: Vitamin D Deficiency
mesh term: Vitamin B 12 Deficiency
mesh term: Folic Acid Deficiency
mesh term: Thyroid Diseases