Skip to main content
OpenTrials
Completed

NCT Number: NCT01438619

Research for the Improvement in Measurement Methods and the Effect of Sodium Intake on Cardiovascular Health

Epidemiological, clinical and animal-experimental evidence shows a direct relationship between dietary sodium intake, blood pressure and cardiovascular event. Diverse questionnaire and 24 hour urinary sodium measurement are used to estimate sodium intake. Complete reflection of eating and cooking habits to the dietary survey method is difficult. Furthermore, the differences of database between countries make it difficult to compare the amount of sodium intake between countries. It is also difficult to consider individual variation of cooking and eating habits. Due to limitations of dietary survey method, WHO recommended 24 hour urinary sodium measurement to estimated sodium intake in the population survey, and many countries are adopting. However, in Korea National Health and Nutrition Examination Survey, only dietary survey method has been used.

The present survey study was designed 1) to test the feasibility of 24 hour urinary sodium measurement for the estimation of sodium intake (including percentage of complete 24 hour urine sample collection) in the population based study; 2) to establish feasible method of 24 hour urinary sodium measurement; 3) to compare 24 hour urinary sodium measurement to the dietary survey method; and 4) to estimate the sodium intake by 24 hour urinary sodium measurement in Goyang city general population (aged 20-70 years).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sodium Intake General Population

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Trial Center, Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 410-773, South Korea

About this study

Measurements: should be performed for 2 days

  • 24 hour urine Na, K and Creatinine, 24 hour urine amount
  • Calculation of urine completeness index : Creatinine/(21 x Bwt)
  • Definition of incomplete urine collection: complete index less than 0.7 and loss of urine more than one time or 100 mL
  • 24 hour ambulatory blood pressure
  • mobile-O-graph (IEM GmbH)
  • measurement interval: 30 minutes
  • Measurement of peripheral blood pressure : microlife WatchBP office
  • Sitting position
  • After 5 minutes resting
  • Peripheral systolic BP (pSBP), Peripheral diastolic BP (pDBP),
  • Central aortic blood pressure
  • SphygmoCor (AtCor Medical, Australia)
  • Central systolic blood pressure
  • Pulse wave velocity
  • VP2000 (Colin, Japan)
  • pulse wave velocity (PWV): carotid-femoral Pulse Wave Velocity, heart-femoral Pulse Wave Velocity and brachial-ankle Pulse Wave Velocity
  • distance measured by tape: distance from suprasternal notch to carotid artery, distance from suprasternal notch to femoral artery
  • Silent environment
  • Electrocardiography
  • Blood chemistry and complete blood count
  • Measure at the morning of first day after overnight fasting
  • complete blood count, blood urea nitrogen/Creatinine, Fasting blood glucose, Total cholesterol, triglyceride, HDL cholesterol

Measurement protocol

  • 1st day
  • Visit hospital before 9:00 AM after overnight fasting
  • Sampling of venous blood
  • start 24 hour urine collection from 9:00 AM (with education for complete collection)
  • start 24 hour ambulatory blood pressure monitoring, in parallel with 24 hour urine collection
  • 2nd day
  • Measure central aortic blood pressure
  • Measure Pulse Wave Velocity
  • Electrocardiography

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • General population who are reside in Goyang city

Exclusion criteria

  • Urinary tract disease
  • Known chronic kidney disease
  • Unable to measure 24 hour ambulatory blood pressure measurement
  • Unable to collect 24 hour urine sample
  • Pregnancy
  • Alcoholics
  • Severe liver disease
  • Night workers
  • Mental retardation

Treatment and study plan

Primary outcomes

  1. Sodium intake in a studied community

    Time frame: Cross-section

    Sodium intake of a community population is measured by 24 hour urinary sodium excretion

Secondary outcomes

  1. The association between 24 hour urinary sodium excretion and ambulatory blood pressure

    Time frame: Cross-sectional

Other outcomes

  1. The relationship between ambulatory blood pressure variability and arterial stiffness

    Time frame: Cross-sectional

Sponsors and collaborators

Lead sponsor

DongGuk University

Other

Collaborators

  • Ministry of Food and Drug Safety, Korea

Registry information

Official study title

Sodium Intake: Research for the Improvement in Measurement Methods and the Effect of Sodium Intake on Cardiovascular Health

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 22, 2011
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.