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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:
Ministry of Food and Drug Safety, Korea
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

September 21, 2011
January 21, 2013
April 2011
November 2011   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01438619 on ClinicalTrials.gov Archive Site
The association between 24 hour urinary sodium excretion and ambulatory blood pressure [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
Not Provided
The relationship between ambulatory blood pressure variability and arterial stiffness [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
Not Provided
 
Research for the Improvement in Measurement Methods and the Effect of Sodium Intake on Cardiovascular Health
Sodium Intake: Research for the Improvement in Measurement Methods and the Effect of Sodium Intake on Cardiovascular Health

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).

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
Observational
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample
  1. Representative population of Goyang city who were randomly selected by digit dialing (RDD) method
  2. Volunteers who are reside in Goyang city
  • Sodium Intake
  • General Population
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
620
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01438619
11162KFDA162, 11162KFDA162
No
Moo-Yong Rhee, DongGuk University
DongGuk University
Ministry of Food and Drug Safety, Korea
Principal Investigator: Moo-Yong Rhee, MD, PhD Clinical Trial Center, Dongguk University Ilsan Hospital
DongGuk University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP