NCT03204422

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 330 (actual)
• Sponsor: Beijing Children's Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 60 Years
• Healthy volunteers: Accepted

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. 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 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

• Urinary Sodium Excretion
• Salt Intakes

Interventions

Type	Name	Description
OTHER	No intervention	no any other intervention

Timeline

• Start date: 2017-02-01
• Primary completion: 2021-08-31
• Completion: 2021-12-31
• First posted: 2017-07-02
• Last updated: 2022-03-02

Locations

1 site across 1 country: China