Outcome Clinical Trial
— OIVITAOfficial title:
Evaluation of the Impact of Mediterranean Lifestyle and Diet on Intermediate and Final Endpoints of Health
Verified date | October 2017 |
Source | Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | May 16, 2024 |
Est. primary completion date | July 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | San Giovanni e Ruggi Hospital | Salerno |
Lead Sponsor | Collaborator |
---|---|
Guido Iaccarino |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | vitamin D profile | vitamin d serum levels will be assessed and compared to the life style | 10 years | |
Other | vitamin B12 profile | vitamin b12 serum levels will be assessed and compared to the life style | 10 years | |
Other | Folic Acid profile | folic acid serum levels will be assessed and compared to the life style | 10 years | |
Primary | cardiovascular events | Presence of events in the anamnesis of subjects enrolled | 10 year | |
Secondary | cardiovascular risk | Framingham Risk Score | 10 years |
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