NCT03204422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

4.6 years

First QC Date

June 28, 2017

Last Update Submit

February 28, 2022

Conditions

Keywords

urinary sodium excretion24-hout urinesalt intakeshypertension

Outcome Measures

Primary Outcomes (1)

  • urinary sodium excretion concentration

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

    day 1

Study Arms (2)

Children's group

no intervention. participants, whose age was 5 to 18 years, were enrolled in Children's group.

Other: No intervention

Adults group

no intervention. participants, whose age was over 18 years, were enrolled in Adults group.

Other: No intervention

Interventions

no any other intervention

Adults groupChildren's group

Eligibility Criteria

Age5 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Aged 5-60 years
  • Provide written informed consent
  • Without any renal diseases or conditions which could affect renal function

You may not qualify if:

  • Pregnant
  • Taking diuretic medicine or pharmaceutical using patients, e.g. some hypertension or heart diseases patients
  • Cancer patients or some other severe patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Children's Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

the 24-h urine sample and the spot urine samples will be required collected and be retained.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Yaguang Peng, PhD

    Beijing Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 2, 2017

Study Start

February 1, 2017

Primary Completion

August 31, 2021

Study Completion

December 31, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations