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Trial record 65 of 123 for:    hypertension "vitamin d"

Observatory on Impact of Life Styles on Health Outcomes (OIVITA)

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ClinicalTrials.gov Identifier: NCT03305276
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Guido Iaccarino, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Brief Summary:
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.

Condition or disease
Outcome

Detailed Description:

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) .


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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Evaluation of the Impact of Mediterranean Lifestyle and Diet on Intermediate and Final Endpoints of Health
Actual Study Start Date : May 16, 2014
Estimated Primary Completion Date : July 16, 2020
Estimated Study Completion Date : May 16, 2024

Group/Cohort
general population
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.



Primary Outcome Measures :
  1. cardiovascular events [ Time Frame: 10 year ]
    Presence of events in the anamnesis of subjects enrolled


Secondary Outcome Measures :
  1. cardiovascular risk [ Time Frame: 10 years ]
    Framingham Risk Score


Other Outcome Measures:
  1. vitamin D profile [ Time Frame: 10 years ]
    vitamin d serum levels will be assessed and compared to the life style

  2. vitamin B12 profile [ Time Frame: 10 years ]
    vitamin b12 serum levels will be assessed and compared to the life style

  3. Folic Acid profile [ Time Frame: 10 years ]
    folic acid serum levels will be assessed and compared to the life style



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Ages Eligible for Study:   14 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteers from Southern Italy will be recruited in occasion of health promoting events in villages.
Criteria

Inclusion Criteria:

- General population

Exclusion Criteria:

  • Subjects who do not sign informed consent and do not give authorization will be excluded from the study
  • Subjects fed through parenteral feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305276


Locations
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Italy
San Giovanni e Ruggi Hospital Recruiting
Salerno, Italy, 84100
Contact: Guido Iaccarino, MD    39089672335    guido.iaccarino@sangiovannieruggi.it   
Sponsors and Collaborators
Guido Iaccarino

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Responsible Party: Guido Iaccarino, Associate Professor of Internal Medicine, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
ClinicalTrials.gov Identifier: NCT03305276     History of Changes
Other Study ID Numbers: 1234
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guido Iaccarino, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona:
diet;
exercise;
hypertension;
vitamin d