- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01438619
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).
Study Overview
Status
Conditions
Detailed Description
Measurements: should be performed for 2 days
24 hour urine Na, K and Creatinine, 24 hour urine amount
- Calculation of urine completeness index : Creatinine/(21 x Bwt)
- Definition of incomplete urine collection: complete index less than 0.7 and loss of urine more than one time or 100 mL
24 hour ambulatory blood pressure
- mobile-O-graph (IEM GmbH)
- measurement interval: 30 minutes
Measurement of peripheral blood pressure : microlife WatchBP office
- Sitting position
- After 5 minutes resting
- Peripheral systolic BP (pSBP), Peripheral diastolic BP (pDBP),
Central aortic blood pressure
- SphygmoCor (AtCor Medical, Australia)
- Central systolic blood pressure
Pulse wave velocity
- VP2000 (Colin, Japan)
- pulse wave velocity (PWV): carotid-femoral Pulse Wave Velocity, heart-femoral Pulse Wave Velocity and brachial-ankle Pulse Wave Velocity
- distance measured by tape: distance from suprasternal notch to carotid artery, distance from suprasternal notch to femoral artery
- Silent environment
- Electrocardiography
Blood chemistry and complete blood count
- Measure at the morning of first day after overnight fasting
- complete blood count, blood urea nitrogen/Creatinine, Fasting blood glucose, Total cholesterol, triglyceride, HDL cholesterol
Measurement protocol
1st day
- Visit hospital before 9:00 AM after overnight fasting
- Sampling of venous blood
- start 24 hour urine collection from 9:00 AM (with education for complete collection)
- start 24 hour ambulatory blood pressure monitoring, in parallel with 24 hour urine collection
2nd day
- Measure central aortic blood pressure
- Measure Pulse Wave Velocity
- Electrocardiography
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Gyeonggi
-
Goyang, Gyeonggi, Korea, Republic of, 410-773
- Clinical Trial Center, Dongguk University Ilsan Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Representative population of Goyang city who were randomly selected by digit dialing (RDD) method
- Volunteers who are reside in Goyang city
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
representitives of Goyang city
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sodium intake in a studied community
Time Frame: Cross-section
|
Sodium intake of a community population is measured by 24 hour urinary sodium excretion
|
Cross-section
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The association between 24 hour urinary sodium excretion and ambulatory blood pressure
Time Frame: Cross-sectional
|
Cross-sectional
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The relationship between ambulatory blood pressure variability and arterial stiffness
Time Frame: Cross-sectional
|
Cross-sectional
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Moo-Yong Rhee, MD, PhD, Clinical Trial Center, Dongguk University Ilsan Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 11162KFDA162 (Other Grant/Funding Number: 11162KFDA162)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on General Population
-
University of BarcelonaUniversitat Oberta de CatalunyaCompletedGeneral PopulationSpain
-
Texas Tech UniversityCompleted
-
BiospectalRecruiting
-
University of ZurichSwiss Federal Institute of TechnologyCompletedGeneral PopulationSwitzerland
-
University of ValenciaCompleted
-
Jordi Gol i Gurina FoundationCatalan Society of Family Medicine; Unitat de Suport a la Recerca, Barcelona...UnknownSedentary General PopulationSpain
-
University of WolverhamptonNot yet recruitingGeneral PopulationUnited Kingdom
-
Institut National de Recherche pour l'Agriculture...CRNH AuvergneRecruiting
-
Lesaffre InternationalNIZO Food ResearchCompleted
-
Charite University, Berlin, GermanyCompletedGeneral PopulationGermany