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

This study has been completed.
Sponsor:
Collaborator:
Korea Food and Drug Administration
Information provided by (Responsible Party):
Moo-Yong Rhee, DongGuk University
ClinicalTrials.gov Identifier:
NCT01438619
First received: September 21, 2011
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition
Sodium Intake
General Population

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Sodium Intake: Research for the Improvement in Measurement Methods and the Effect of Sodium Intake on Cardiovascular Health

Further study details as provided by DongGuk University:

Primary Outcome Measures:
  • Sodium intake in a studied community [ Time Frame: Cross-section ] [ Designated as safety issue: No ]
    Sodium intake of a community population is measured by 24 hour urinary sodium excretion


Secondary Outcome Measures:
  • The association between 24 hour urinary sodium excretion and ambulatory blood pressure [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The relationship between ambulatory blood pressure variability and arterial stiffness [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]

Enrollment: 620
Study Start Date: April 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

Measurements: should be performed for 2 days

  1. 24 hour urine Na, K and Creatinine, 24 hour urine amount

    1. Calculation of urine completeness index : Creatinine/(21 x Bwt)
    2. Definition of incomplete urine collection: complete index less than 0.7 and loss of urine more than one time or 100 mL

  2. 24 hour ambulatory blood pressure

    1. mobile-O-graph (IEM GmbH)
    2. measurement interval: 30 minutes

  3. Measurement of peripheral blood pressure : microlife WatchBP office

    1. Sitting position
    2. After 5 minutes resting
    3. Peripheral systolic BP (pSBP), Peripheral diastolic BP (pDBP),

  4. Central aortic blood pressure

    1. SphygmoCor (AtCor Medical, Australia)
    2. Central systolic blood pressure

  5. Pulse wave velocity

    1. VP2000 (Colin, Japan)
    2. pulse wave velocity (PWV): carotid-femoral Pulse Wave Velocity, heart-femoral Pulse Wave Velocity and brachial-ankle Pulse Wave Velocity
    3. distance measured by tape: distance from suprasternal notch to carotid artery, distance from suprasternal notch to femoral artery
    4. Silent environment
  6. Electrocardiography

  7. Blood chemistry and complete blood count

    1. Measure at the morning of first day after overnight fasting
    2. complete blood count, blood urea nitrogen/Creatinine, Fasting blood glucose, Total cholesterol, triglyceride, HDL cholesterol

Measurement protocol

  1. 1st day

    1. Visit hospital before 9:00 AM after overnight fasting
    2. Sampling of venous blood
    3. start 24 hour urine collection from 9:00 AM (with education for complete collection)
    4. start 24 hour ambulatory blood pressure monitoring, in parallel with 24 hour urine collection

  2. 2nd day

    1. Measure central aortic blood pressure
    2. Measure Pulse Wave Velocity
    3. Electrocardiography
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

  • General population who are reside in Goyang city

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438619

Locations
Korea, Republic of
Clinical Trial Center, Dongguk University Ilsan Hospital
Goyang, Gyeonggi, Korea, Republic of, 410-773
Sponsors and Collaborators
DongGuk University
Korea Food and Drug Administration
Investigators
Principal Investigator: Moo-Yong Rhee, MD, PhD Clinical Trial Center, Dongguk University Ilsan Hospital
  More Information

No publications provided

Responsible Party: Moo-Yong Rhee, Professor, DongGuk University
ClinicalTrials.gov Identifier: NCT01438619     History of Changes
Other Study ID Numbers: 11162KFDA162, 11162KFDA162
Study First Received: September 21, 2011
Last Updated: January 21, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by DongGuk University:
sodium
blood pressure
pulse wave velocity
random digit dialling

ClinicalTrials.gov processed this record on May 19, 2013