Estimation Method of 24-hour Urinary Sodium Excretion by Using Spot Urine for Chinese Population
NCT ID: NCT03204422
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
330 participants
OBSERVATIONAL
2017-02-01
2021-12-31
Brief Summary
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Detailed Description
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1. 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.
2. Validate previous finding that 24-h USE is estimated inaccurately by using only the second morning void.
3. 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
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Children's group
no intervention. participants, whose age was 5 to 18 years, were enrolled in Children's group.
No intervention
no any other intervention
Adults group
no intervention. participants, whose age was over 18 years, were enrolled in Adults group.
No intervention
no any other intervention
Interventions
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No intervention
no any other intervention
Eligibility Criteria
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Inclusion Criteria
* Provide written informed consent
* Without any renal diseases or conditions which could affect renal function
Exclusion Criteria
* Taking diuretic medicine or pharmaceutical using patients, e.g. some hypertension or heart diseases patients
* Cancer patients or some other severe patient
5 Years
60 Years
ALL
Yes
Sponsors
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Capital Medical University
OTHER
Beijing Children's Hospital
OTHER
Responsible Party
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Yaguang Peng
research assistant
Principal Investigators
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Yaguang Peng, PhD
Role: PRINCIPAL_INVESTIGATOR
Beijing Children's Hospital
Locations
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Beijing Children's Hospital
Beijing, , China
Countries
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Other Identifiers
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17JL85
Identifier Type: -
Identifier Source: org_study_id
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