NCT03305276

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2020

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2024

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

6.2 years

First QC Date

July 6, 2017

Last Update Submit

October 3, 2017

Conditions

Outcome

Keywords

diet;exercise;hypertension;vitamin d

Outcome Measures

Primary Outcomes (1)

  • cardiovascular events

    Presence of events in the anamnesis of subjects enrolled

    10 year

Secondary Outcomes (1)

  • cardiovascular risk

    10 years

Other Outcomes (3)

  • vitamin D profile

    10 years

  • vitamin B12 profile

    10 years

  • Folic Acid profile

    10 years

Study Arms (1)

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.

Eligibility Criteria

Age14 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Volunteers from Southern Italy will be recruited in occasion of health promoting events in villages.

You may qualify if:

  • \- General population

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Giovanni e Ruggi Hospital

Salerno, 84100, Italy

RECRUITING

MeSH Terms

Conditions

Motor ActivityHypertension

Condition Hierarchy (Ancestors)

BehaviorVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

July 6, 2017

First Posted

October 9, 2017

Study Start

May 16, 2014

Primary Completion

July 16, 2020

Study Completion

May 16, 2024

Last Updated

October 9, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)