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

Sponsor
Beijing Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03204422
Collaborator
Capital Medical University (Other)
330
1
58.9
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
330 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
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
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. urinary sodium excretion concentration [day 1]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Children's Hospital Beijing China

Sponsors and Collaborators

  • Beijing Children's Hospital
  • Capital Medical University

Investigators

  • Principal Investigator: Yaguang Peng, PhD, Beijing Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yaguang Peng, research assistant, Beijing Children's Hospital
ClinicalTrials.gov Identifier:
NCT03204422
Other Study ID Numbers:
  • 17JL85
First Posted:
Jul 2, 2017
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yaguang Peng, research assistant, Beijing Children's Hospital

Study Results

No Results Posted as of Mar 2, 2022