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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01438619
Enrollment
620
Registered
2011-09-22
Start date
2011-04-30
Completion date
2011-11-30
Last updated
2013-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Population, Sodium Intake

Keywords

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

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).

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

Interventions

None listed

Sponsors

Ministry of Food and Drug Safety, Korea
CollaboratorOTHER_GOV
DongGuk University
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sodium intake in a studied communityCross-sectionSodium intake of a community population is measured by 24 hour urinary sodium excretion

Secondary

MeasureTime frame
The association between 24 hour urinary sodium excretion and ambulatory blood pressureCross-sectional

Other

MeasureTime frame
The relationship between ambulatory blood pressure variability and arterial stiffnessCross-sectional

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026