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

Salt Intakes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204422
• Other study ID #: 17JL85
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Beijing Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Salt Intakes
• Urinary Sodium Excretion

Intervention

Other:
• No intervention
no any other intervention

Locations

Country	Name	City	State
China	Beijing Children's Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Children's Hospital	Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary sodium excretion concentration	the concentration measured by laboratory examination for the 24 hour urine sample and spot urine samples	day 1