Observatory on Impact of Life Styles on Health Outcomes

Outcome Clinical Trial

— OIVITA  

Official title:

Evaluation of the Impact of Mediterranean Lifestyle and Diet on Intermediate and Final Endpoints of Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03305276
• Other study ID #: 1234
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2017
• Last updated: October 3, 2017
• Start date: May 16, 2014
• Est. completion date: May 16, 2024

Study information

• Verified date: October 2017
• Source: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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) .

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Outcome

Locations

Country	Name	City	State
Italy	San Giovanni e Ruggi Hospital	Salerno

Sponsors (1)

Lead Sponsor	Collaborator
Guido Iaccarino

Country where clinical trial is conducted

Italy, 

Outcome

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