Research for the Improvement in Measurement Methods and the Effect of Sodium Intake on Cardiovascular Health

NCT01438619 | Completed

• 1 other identifier: 11162KFDA162
• Study Type: observational
• Target: 620
• Locations: 1 country
• Sites: 1

Brief Summary

Epidemiological, clinical and animal-experimental evidence shows a direct relationship between dietary sodium intake, blood pressure and cardiovascular event. Diverse questionnaire and 24 hour urinary sodium measurement are used to estimate sodium intake. Complete reflection of eating and cooking habits to the dietary survey method is difficult. Furthermore, the differences of database between countries make it difficult to compare the amount of sodium intake between countries. It is also difficult to consider individual variation of cooking and eating habits. Due to limitations of dietary survey method, WHO recommended 24 hour urinary sodium measurement to estimated sodium intake in the population survey, and many countries are adopting. However, in Korea National Health and Nutrition Examination Survey, only dietary survey method has been used. The present survey study was designed 1) to test the feasibility of 24 hour urinary sodium measurement for the estimation of sodium intake (including percentage of complete 24 hour urine sample collection) in the population based study; 2) to establish feasible method of 24 hour urinary sodium measurement; 3) to compare 24 hour urinary sodium measurement to the dietary survey method; and 4) to estimate the sodium intake by 24 hour urinary sodium measurement in Goyang city general population (aged 20-70 years).

Conditions

Sodium Intake; General Population

Keywords

sodium; blood pressure; pulse wave velocity; random digit dialling

Outcome Measures

Primary Outcomes (1)

• Sodium intake in a studied community

  Sodium intake of a community population is measured by 24 hour urinary sodium excretion

  Cross-section

Secondary Outcomes (1)

• The association between 24 hour urinary sodium excretion and ambulatory blood pressure

  Cross-sectional

Other Outcomes (1)

• The relationship between ambulatory blood pressure variability and arterial stiffness

  Cross-sectional

Study Arms (1)

representitives of Goyang city

1. Representative population of Goyang city who were randomly selected by digit dialing (RDD) method 2. Volunteers who are reside in Goyang city

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Representative population of Goyang city who were randomly selected by digit dialing (RDD) method 2. Volunteers who are reside in Goyang city

You may qualify if:

• General population who are reside in Goyang city

You may not qualify if:

• Urinary tract disease
• Known chronic kidney disease
• Unable to measure 24 hour ambulatory blood pressure measurement
• Unable to collect 24 hour urine sample
• Pregnancy
• Alcoholics
• Severe liver disease
• Night workers
• Mental retardation

Sponsors & Collaborators

• DongGuk University: lead
• Ministry of Food and Drug Safety, Korea: collaborator

Study Sites (1)

Clinical Trial Center, Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 410-773, South Korea

Location

Study Officials

• Moo-Yong Rhee, MD, PhD

  Clinical Trial Center, Dongguk University Ilsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 22, 2011
• Study Start: April 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

KR (1)