Sodium IntakeNCT01438619
Research for the Improvement in Measurement Methods and the Effect of Sodium Intake on Cardiovascular Health
An observational study of Sodium Intake and General Population, run by DongGuk University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sodium Intake, General Population
- How many people
- 620 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- General population who are reside in Goyang city
Who cannot join
- 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
Show all 9Show fewer
- Severe liver disease
- Night workers
- Mental retardation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center, Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 410-773
About this study
Official title: 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).
Read the 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
- Conditions
- Sodium Intake, General Population
- Keywords
- sodium, blood pressure, pulse wave velocity, random digit dialling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium intake in a studied community
Sodium intake of a community population is measured by 24 hour urinary sodium excretion
Measured: Cross-section
Secondary outcomes (1)
The association between 24 hour urinary sodium excretion and ambulatory blood pressure
Measured: Cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Responsible party
- Principal investigator, Moo-Yong Rhee, DongGuk University
- Investigators
- Moo-Yong Rhee, MD, PhD, Principal investigator, Clinical Trial Center, Dongguk University Ilsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438619
- Sponsor's protocol ID
- 11162KFDA162
- Other IDs
- 11162KFDA162
- Status last verified
- Jan 2013
- First submitted
- 21 Sep 2011
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Intake: Research for the Improvement in Measurement Methods and the Effect of Sodium Intake on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT01438619
- Acronym / sponsor ID
- 11162KFDA162
- Conditions
- Sodium Intake, General Population
- Keywords
- sodium, blood pressure, pulse wave velocity, random digit dialling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Study start
- Apr 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 22 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- General population who are reside in Goyang city
Key exclusion criteria (9 listed)
- Urinary tract disease
- Known chronic kidney disease
- Unable to measure 24 hour ambulatory blood pressure measurement
- Unable to collect 24 hour urine sample
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sodium intake in a studied community
Time frame: Cross-section
Sodium intake of a community population is measured by 24 hour urinary sodium excretion
1 secondary outcome
The association between 24 hour urinary sodium excretion and ambulatory blood pressure
Time frame: Cross-sectional
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moo-Yong Rhee, MD, PhD principal investigator
Clinical Trial Center, Dongguk University Ilsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sodium Intake and General Population, run by DongGuk University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sodium intake in a studied community (time frame: Cross-section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.