<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/NCT03305276</url>
  </required_header>
  <id_info>
    <org_study_id>1234</org_study_id>
    <nct_id>NCT03305276</nct_id>
  </id_info>
  <brief_title>Observatory on Impact of Life Styles on Health Outcomes</brief_title>
  <acronym>OIVITA</acronym>
  <official_title>Evaluation of the Impact of Mediterranean Lifestyle and Diet on Intermediate and Final Endpoints of Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guido Iaccarino</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona</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>
      The present is an observational study conducted on the general population in villages of&#xD;
      Southern Italy every year during the world hypertension day. So far, A total of 412 persons&#xD;
      (193 males and 219 female, 14-85 years) were recruited during the XI and XII World&#xD;
      Hypertension Day (2015 and 2016). The study was approved by the relevant institutional&#xD;
      Ethical Committee of Salerno University.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In occasion of the World Hypertension Day in may , boots are organized in the major squares&#xD;
      of the southern italy villages, and volunteers of the Medical School of Salerno collect&#xD;
      through means of questionnaires, anamnestic data and dietary habits, and measure blood&#xD;
      pressure after 5 minutes in the sitting position, 3 times with an interval of 2 minutes using&#xD;
      validated, ESH approved electronic oscillometer (A100, Microlife, Italy), according to the&#xD;
      ESC/ESH guidelines. Other questions regard previous cardiovascular conditions or events&#xD;
      (coronary heart disease) and cardiovascular accidents (TIA and stroke). Eventual drug&#xD;
      treatment and Vitamin D supplementation is also annotated. A venous blood sample is drawn&#xD;
      from the antecubital vein and blood is stored for biochemical analysis at the University&#xD;
      Hospital Centralized Service. Data are digitally stored for analysis.&#xD;
&#xD;
      Anamnestic and biochemical data regarding age, sex-specific cholesterol, HDL cholesterol,&#xD;
      systolic BP and cigarette smoking pre-existing conditions and way of life are used for the&#xD;
      calculation of cardiovascular risk according to the Framingham Cardiovascular Risk Score.&#xD;
      Familiarity for cardiovascular disease is defined as cardiovascular events in parents and&#xD;
      siblings less than 50 years old.&#xD;
&#xD;
      The validated questionnaire alternate Mediterranean Diet Score (aMed), is administered to&#xD;
      assess adherence to the Mediterranean Diet . Laboratory assessment of blood samples. A venous&#xD;
      blood sample was collected in two tubes of 5.0 ml and centrifuged in the day. The time of the&#xD;
      last meal was recorded during the data collection. Blood glucose, insulin, blood urea&#xD;
      nitrogen (BUN), creatinine, calcium, phosphorus, total cholesterol, HDL cholesterol, LDL&#xD;
      cholesterol, triglycerides, 25(OH)D, PTH, Vitamin B-12 and folic acid are assessed.&#xD;
      Glomerular filtration rate (GFRs) is estimated using the equation of Chronic Kidney Disease&#xD;
      Epidemiology Collaboration (CKD-EPI) .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 16, 2014</start_date>
  <completion_date type="Anticipated">May 16, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 16, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cardiovascular events</measure>
    <time_frame>10 year</time_frame>
    <description>Presence of events in the anamnesis of subjects enrolled</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cardiovascular risk</measure>
    <time_frame>10 years</time_frame>
    <description>Framingham Risk Score</description>
  </secondary_outcome>
  <other_outcome>
    <measure>vitamin D profile</measure>
    <time_frame>10 years</time_frame>
    <description>vitamin d serum levels will be assessed and compared to the life style</description>
  </other_outcome>
  <other_outcome>
    <measure>vitamin B12 profile</measure>
    <time_frame>10 years</time_frame>
    <description>vitamin b12 serum levels will be assessed and compared to the life style</description>
  </other_outcome>
  <other_outcome>
    <measure>Folic Acid profile</measure>
    <time_frame>10 years</time_frame>
    <description>folic acid serum levels will be assessed and compared to the life style</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Outcome</condition>
  <arm_group>
    <arm_group_label>general population</arm_group_label>
    <description>the study is open to all population, (14-90 years, male/female) to verify the impact of lifestyles (mediterranean style) on intermediate and hard endpoint.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Volunteers from Southern Italy will be recruited in occasion of health promoting events in&#xD;
        villages.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - General population&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who do not sign informed consent and do not give authorization will be&#xD;
             excluded from the study&#xD;
&#xD;
          -  Subjects fed through parenteral feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>San Giovanni e Ruggi Hospital</name>
      <address>
        <city>Salerno</city>
        <zip>84100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guido Iaccarino, MD</last_name>
      <phone>39089672335</phone>
      <email>guido.iaccarino@sangiovannieruggi.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona</investigator_affiliation>
    <investigator_full_name>Guido Iaccarino</investigator_full_name>
    <investigator_title>Associate Professor of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>diet;</keyword>
  <keyword>exercise;</keyword>
  <keyword>hypertension;</keyword>
  <keyword>vitamin d</keyword>
  <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/NCT03305276
org study id: 1234
nct id: NCT03305276
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present is an observational study conducted on the general population in villages of
      Southern Italy every year during the world hypertension day. So far, A total of 412 persons
      (193 males and 219 female, 14-85 years) were recruited during the XI and XII World
      Hypertension Day (2015 and 2016). The study was approved by the relevant institutional
      Ethical Committee of Salerno University.
In occasion of the World Hypertension Day in may , boots are organized in the major squares
      of the southern italy villages, and volunteers of the Medical School of Salerno collect
      through means of questionnaires, anamnestic data and dietary habits, and measure blood
      pressure after 5 minutes in the sitting position, 3 times with an interval of 2 minutes using
      validated, ESH approved electronic oscillometer (A100, Microlife, Italy), according to the
      ESC/ESH guidelines. Other questions regard previous cardiovascular conditions or events
      (coronary heart disease) and cardiovascular accidents (TIA and stroke). Eventual drug
      treatment and Vitamin D supplementation is also annotated. A venous blood sample is drawn
      from the antecubital vein and blood is stored for biochemical analysis at the University
      Hospital Centralized Service. Data are digitally stored for analysis.

      Anamnestic and biochemical data regarding age, sex-specific cholesterol, HDL cholesterol,
      systolic BP and cigarette smoking pre-existing conditions and way of life are used for the
      calculation of cardiovascular risk according to the Framingham Cardiovascular Risk Score.
      Familiarity for cardiovascular disease is defined as cardiovascular events in parents and
      siblings less than 50 years old.

      The validated questionnaire alternate Mediterranean Diet Score (aMed), is administered to
      assess adherence to the Mediterranean Diet . Laboratory assessment of blood samples. A venous
      blood sample was collected in two tubes of 5.0 ml and centrifuged in the day. The time of the
      last meal was recorded during the data collection. Blood glucose, insulin, blood urea
      nitrogen (BUN), creatinine, calcium, phosphorus, total cholesterol, HDL cholesterol, LDL
      cholesterol, triglycerides, 25(OH)D, PTH, Vitamin B-12 and folic acid are assessed.
      Glomerular filtration rate (GFRs) is estimated using the equation of Chronic Kidney Disease
      Epidemiology Collaboration (CKD-EPI) .
observational model: Ecologic or Community
time perspective: Retrospective
measure: cardiovascular events
time frame: 10 year
description: Presence of events in the anamnesis of subjects enrolled
measure: cardiovascular risk
time frame: 10 years
description: Framingham Risk Score
measure: vitamin D profile
time frame: 10 years
description: vitamin d serum levels will be assessed and compared to the life style
measure: vitamin B12 profile
time frame: 10 years
description: vitamin b12 serum levels will be assessed and compared to the life style
measure: Folic Acid profile
time frame: 10 years
description: folic acid serum levels will be assessed and compared to the life style
arm group label: general population
description: the study is open to all population, (14-90 years, male/female) to verify the impact of lifestyles (mediterranean style) on intermediate and hard endpoint.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor-Investigator
investigator affiliation: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
investigator full name: Guido Iaccarino
investigator title: Associate Professor of Internal Medicine
sharing ipd: No