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
|Condition or disease|
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) .
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Observational Model:||Ecologic or Community|
|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|
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.
- cardiovascular events [ Time Frame: 10 year ]Presence of events in the anamnesis of subjects enrolled
- cardiovascular risk [ Time Frame: 10 years ]Framingham Risk Score
- vitamin D profile [ Time Frame: 10 years ]vitamin d serum levels will be assessed and compared to the life style
- vitamin B12 profile [ Time Frame: 10 years ]vitamin b12 serum levels will be assessed and compared to the life style
- Folic Acid profile [ Time Frame: 10 years ]folic acid serum levels will be assessed and compared to the life style
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305276
|San Giovanni e Ruggi Hospital||Recruiting|
|Salerno, Italy, 84100|
|Contact: Guido Iaccarino, MD 39089672335 firstname.lastname@example.org|