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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Sodium Excretion; Salt Intakes
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The children participants will be childrens from children's health care center and some inhospital patients from ophthalmology and orthopaedics ward in Beijing Children's Hospital.

The adult participants will be residents from community.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children's group; no intervention. participants, whose age was 5 to 18 years, were enrolled in Children's group.	Other: No intervention; no any other intervention
Adults group; no intervention. participants, whose age was over 18 years, were enrolled in Adults group.	Other: No intervention; no any other intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Children's Hospital
• Collaborators: Capital Medical University
• Investigators: Principal Investigator: Yaguang Peng, PhD, Beijing Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: hypertension; urinary sodium excretion; 24-hout urine; salt intakes
• Other Study ID Numbers: 17JL85

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No