Clinical trial NCT03204422: Estimation Method of 24-hour Urinary Sodium Excretion by Using Spot Urine for Chinese Population
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Sodium Excretion
Salt Intakes
Keywords: urinary sodium excretion
24-hout urine
salt intakes
hypertension
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
Collaborators: name: Capital Medical University
First posted: 2017-07-02
Enrollment: 330
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: urinary sodium excretion concentration
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital
Study officials:
affiliation: Beijing Children's Hospital
name: Yaguang Peng, PhD
role: PRINCIPAL_INVESTIGATOR
References: