Estimation Method of 24-hour Urinary Sodium Excretion by Using Spot Urine for Chinese Population

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Exploratory and Validation Study of Estimation Method of 24-hour Urinary Sodium Excretion by Using Spot Urine for Chinese Children and Adults

Conditions
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Urinary Sodium Excretion, Salt Intakes

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 5-60 years Provide written informed consent Without any renal diseases or conditions which could affect renal function Exclusion Criteria: Pregnant Taking diuretic medicine or pharmaceutical using patients, e.g. some hypertension or heart diseases patients Cancer patients or some other severe patient

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children's group<br>no intervention. participants, whose age was 5 to 18 years, were enrolled in Children's group. | Other: No intervention<br>* no any other intervention<br>|
| Adults group<br>no intervention. participants, whose age was over 18 years, were enrolled in Adults group. | Other: No intervention<br>* no any other intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary sodium excretion concentration | the concentration measured by laboratory examination for the 24 hour urine sample and spot urine samples | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary sodium excretion, 24-hout urine, salt intakes, hypertension