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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2021-12-31

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

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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Urinary Sodium Excretion Salt Intakes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type OTHER

no any other intervention

Adults group

no intervention. participants, whose age was over 18 years, were enrolled in Adults group.

No intervention

Intervention Type OTHER

no any other intervention

Interventions

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No intervention

no any other intervention

Intervention Type OTHER

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Capital Medical University

OTHER

Sponsor Role collaborator

Beijing Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yaguang Peng

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

Other Identifiers

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17JL85

Identifier Type: -

Identifier Source: org_study_id

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