Chronic Kidney DiseaseNCT01960608
The Analysis of Correlation About the Spot Urine Sodium and the Blood Pressure in General Population According to the Income Level
An observational study of Chronic Kidney Disease, run by Inje University at 1 site in South Korea.
Trial summary
Increasing sodium intake raises blood pressure. And high salt intake could hinder the management of chronic disease. Much previous research has confirmed that dietary habits are affected by economic status. So we compared sodium intake with economic status. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- 24_hours_urine_sodium
- How many people
- 7,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Jan 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: general population
Who may be able to join
- all the patient who participated in the national survey
Who cannot join
- no pregnancy
- malignancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Inje University Seoul Paik Hospital
Seoul, Seoul, 100-032
About this study
Increasing sodium intake raises blood pressure. And high salt intake could hinder the management of chronic disease. Much previous research has confirmed that dietary habits are affected by economic status. So we compared sodium intake with economic status. We investigated the prevalence, extent and management, and the relevance of sodium intake with income level.
- Conditions
- Chronic Kidney Disease
- Being tested
- 24_hours_urine_sodium
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24_hours_urine_sodiumOther
| Study group | Role | What they receive |
|---|---|---|
| low sodium group | 24_hours_urine_sodium < 100 mEq/L Receives: Other: 24_hours_urine_sodium | |
| mid sodium group | 24_hours_urine_sodium >= 100 mEq/L and < 200 mEq/L Receives: Other: 24_hours_urine_sodium | |
| high sodium group | 24_hours_urine_sodium >= 200 mEq/L Receives: Other: 24_hours_urine_sodium | |
| low income group | the income 25% below the quartile | |
| low mid income group | the income 25% - 50% below the quartile | |
| mid income group | the income 50% - 75% below the quartile | |
| high income group | the income 75% over the quartile |
What is being measured
The primary outcome is the main question the study is designed to answer.
sodium intake and the degree of control of blood pressure in general population according to the income level
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startJan 2015
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Time perspective
- Retrospective
- Enrolment
- 7,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoseok Koo, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960608
- Sponsor's protocol ID
- sodium_income
- Status last verified
- Mar 2016
- First submitted
- 6 Oct 2013
- Last updated
- 30 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of Correlation About the Spot Urine Sodium and the Blood Pressure in General Population According to the Income Level
- ClinicalTrials.gov ID
- NCT01960608
- Acronym / sponsor ID
- sodium_income
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2015 (actual)
- First posted
- 10 Oct 2013 (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.
Increasing sodium intake raises blood pressure. And high salt intake could hinder the management of chronic disease. Much previous research has confirmed that dietary habits are affected by economic status. So we compared sodium intake with economic status. We investigated the prevalence, extent and management, and the relevance of sodium intake with income level.
Study design
- Time perspective
- Retrospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| low sodium group | – | Other: 24_hours_urine_sodium24_hours_urine_sodium < 100 mEq/L |
| mid sodium group | – | Other: 24_hours_urine_sodium24_hours_urine_sodium >= 100 mEq/L and < 200 mEq/L |
| high sodium group | – | Other: 24_hours_urine_sodium24_hours_urine_sodium >= 200 mEq/L |
| low income group | – | –the income 25% below the quartile |
| low mid income group | – | –the income 25% - 50% below the quartile |
| mid income group | – | –the income 50% - 75% below the quartile |
| high income group | – | –the income 75% over the quartile |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- general population
Key inclusion criteria (1 listed)
- all the patient who participated in the national survey
Key exclusion criteria (2 listed)
- no pregnancy
- malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24_hours_urine_sodium | Other | high sodium group, low sodium group, mid sodium group |
Primary outcome
sodium intake and the degree of control of blood pressure in general population according to the income level
Time frame: 1 year
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 30 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Kidney Disease, run by Inje 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 2 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 30 Mar 2016. 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 and the degree of control of blood pressure in general population according to the income level (time frame: 1 year). 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 30 Mar 2016.