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Completed

NCT Number: NCT03204422

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

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.

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Key information

Age range

5 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Children's Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no any other intervention

Primary outcomes

  1. urinary sodium excretion concentration

    Time frame: day 1

    the concentration measured by laboratory examination for the 24 hour urine sample and spot urine samples

Sponsors and collaborators

Lead sponsor

Beijing Children's Hospital

Other

Collaborators

  • Capital Medical University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2017
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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