Urinary Sodium ExcretionNCT03204422
Estimation Method of 24-hour Urinary Sodium Excretion by Using Spot Urine for Chinese Population
An observational study of Urinary Sodium Excretion and Salt Intakes, run by Beijing Children's Hospital at 1 site in China.
Trial summary
The accurate evaluation of daily salt or sodium intake is difficult to implement in clinical practice and large epidemiological studies. 24-h urinary sodium excretion (USE) is considered the gold standard, but is expensive and has a high participant burden. Read more about this study
- Who is it for?
- Ages 5 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Sodium Excretion, Salt Intakes
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 31 Dec 2021
- 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 5 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The children participants will be childrens from children's health care center and some inhospital patients from ophthalmology and orthopaedics ward in Beijing Children's Hospital. The adult participants will be residents from community.
Who may be able to join
- Aged 5-60 years
- Provide written informed consent
- Without any renal diseases or conditions which could affect renal function
Who cannot join
- Pregnant
- Taking diuretic medicine or pharmaceutical using patients, e.g. some hypertension or heart diseases patients
- Cancer patients or some other severe patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Exploratory and Validation Study of Estimation Method of 24-hour Urinary Sodium Excretion by Using Spot Urine for Chinese Children and Adults
The accurate evaluation of daily salt or sodium intake is difficult to implement in clinical practice and large epidemiological studies. 24-h urinary sodium excretion (USE) is considered the gold standard, but is expensive and has a high participant burden. To further explore the association between 24-h USE and spot urines in Chinese population, it was proposed that using collected multiple spot urine samples could be estimated for 24-h USE in Chinese children and adults.
Read the detailed description
Specific Aims
- To collect multiple spot urine samples and a 24-h urine sample in a population of Chinese Children and adults. All participants will collect a spot urine in separate jugs during the 24-h period, recording every urination time.
- Validate previous finding that 24-h USE is estimated inaccurately by using only the second morning void.
- Explore a statistical formula to estimate 24-h USE by multi-time spot urine. The study plan to enroll 200 children and 100 adults to collect a whole 24-h urine spot by spot continuously. After a laboratory examination of sodium concentration from both spot urine samples and 24-h urine sample, the exploratory estimation using multi-spot urine to assess 24-h urinary sodium excretion will analyzed statistically. The validation for the estimation method will be conducted in Chinese population as well.
Urine sodium and potassium concentration in each urine specimen will be determined by ion selective electrode methods and creatinine using enzymatic methods.The model established by using linear model step by step. And the validation analysis conducted through correlation analysis, bias distribution, residual analysis and Bland-Altman plot to assess accuracy. All statistics analysis will be conducted using Statistical Analysis System software version 9.4.
- Conditions
- Urinary Sodium Excretion, Salt Intakes
- Being tested
- No intervention
- Keywords
- urinary sodium excretion, 24-hout urine, salt intakes, hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
no any other intervention
| Study group | Role | What they receive |
|---|---|---|
| Children's group | no intervention. participants, whose age was 5 to 18 years, were enrolled in Children's group. Receives: Other: No intervention | |
| Adults group | no intervention. participants, whose age was over 18 years, were enrolled in Adults group. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary sodium excretion concentration
the concentration measured by laboratory examination for the 24 hour urine sample and spot urine samples
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Feb 2017
- Primary completion31 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Sodium ExcretionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University
- Responsible party
- Principal investigator, Yaguang Peng, Beijing Children's Hospital
- Investigators
- Yaguang Peng, PhD, Principal investigator, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204422
- Sponsor's protocol ID
- 17JL85
- Status last verified
- Feb 2022
- First submitted
- 28 Jun 2017
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploratory and Validation Study of Estimation Method of 24-hour Urinary Sodium Excretion by Using Spot Urine for Chinese Children and Adults
- ClinicalTrials.gov ID
- NCT03204422
- Acronym / sponsor ID
- 17JL85
- Conditions
- Urinary Sodium Excretion, Salt Intakes
- Keywords
- urinary sodium excretion, 24-hout urine, salt intakes, hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Collaborators
- Capital Medical University
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Jul 2017 (actual)
- 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.
The accurate evaluation of daily salt or sodium intake is difficult to implement in clinical practice and large epidemiological studies. 24-h urinary sodium excretion (USE) is considered the gold standard, but is expensive and has a high participant burden. To further explore the association between 24-h USE and spot urines in Chinese population, it was proposed that using collected multiple spot urine samples could be estimated for 24-h USE in Chinese children and adults.
Detailed description
Specific Aims
- To collect multiple spot urine samples and a 24-h urine sample in a population of Chinese Children and adults. All participants will collect a spot urine in separate jugs during the 24-h period, recording every urination time.
- Validate previous finding that 24-h USE is estimated inaccurately by using only the second morning void.
- Explore a statistical formula to estimate 24-h USE by multi-time spot urine. The study plan to enroll 200 children and 100 adults to collect a whole 24-h urine spot by spot continuously. After a laboratory examination of sodium concentration from both spot urine samples and 24-h urine sample, the exploratory estimation using multi-spot urine to assess 24-h urinary sodium excretion will analyzed statistically. The validation for the estimation method will be conducted in Chinese population as well.
Urine sodium and potassium concentration in each urine specimen will be determined by ion selective electrode methods and creatinine using enzymatic methods.The model established by using linear model step by step. And the validation analysis conducted through correlation analysis, bias distribution, residual analysis and Bland-Altman plot to assess accuracy. All statistics analysis will be conducted using Statistical Analysis System software version 9.4.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children's group | – | Other: No interventionno intervention. participants, whose age was 5 to 18 years, were enrolled in Children's group. |
| Adults group | – | Other: No interventionno intervention. participants, whose age was over 18 years, were enrolled in Adults group. |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The children participants will be childrens from children's health care center and some inhospital patients from ophthalmology and orthopaedics ward in Beijing Children's Hospital. The adult participants will be residents from community.
Key inclusion criteria (3 listed)
- Aged 5-60 years
- Provide written informed consent
- Without any renal diseases or conditions which could affect renal function
Key exclusion criteria (3 listed)
- Pregnant
- Taking diuretic medicine or pharmaceutical using patients, e.g. some hypertension or heart diseases patients
- Cancer patients or some other severe patient
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 |
|---|---|---|
| No interventionno any other intervention | Other | Adults group, Children's group |
Primary outcome
urinary sodium excretion concentration
Time frame: day 1
the concentration measured by laboratory examination for the 24 hour urine sample and spot urine samples
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 2 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Urinary Sodium Excretion
Enrolling by invitationObservational study
Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children
Urinary Sodium Excretion, Salt Intakes
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.
Yaguang Peng, PhD principal investigator
Beijing Children's 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 Urinary Sodium Excretion and Salt Intakes, run by Beijing Children's Hospital at 1 site in China.
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 3 inclusion and 3 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 2 Mar 2022. 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 China. 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?
urinary sodium excretion concentration (time frame: day 1). 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 2 Mar 2022.