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NHANES Urinary Sodium Calibration Study

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01631240
First received: June 11, 2012
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  Purpose

This proposed calibration study is designed to evaluate the correlation of urinary sodium excretion between NHANES timed urine and 24-hour urine collections.


Condition
24-hour Urine Sodium (and Related Nutrient) Excretion

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: National Health and Nutrition Examination Survey (NHANES), Urinary Sodium Calibration Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Usual sodium intake [ Time Frame: one day ] [ Designated as safety issue: No ]
    Usual sodium intake based on 24-hour sodium excretions (two measurements for a one-third subset 4-11 days after the first collection) using measurement error models


Secondary Outcome Measures:
  • Usual potassium intake [ Time Frame: one day ] [ Designated as safety issue: No ]
    Usual potassium intake based on 24-hour potassium excretions (two measurements for a one-third subset) using measurement error models

  • Creatinine excretion [ Time Frame: one day ] [ Designated as safety issue: No ]
    Based on 24-hour creatinine excretion

  • Usual iodine intake [ Time Frame: one day ] [ Designated as safety issue: No ]
    Usual sodium intake based on 24-hour sodium excretions (two measurements for a one-third subset 4-11 days after the first collection) using measurement error models


Biospecimen Retention:   Samples Without DNA

urine specimens


Enrollment: 441
Study Start Date: June 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adults 18-39 years
Healthy adults aged 18-39 years

Detailed Description:

The study will be conducted with 400 volunteer participants aged 18-39 years old. Participants will be asked to collect urine samples over a 24-hour period. One-third of the participants (n=133) will be asked to collect a second 24-hour urine 4-11 days later. A 24-hour dietary recall interview will be collected after the completion of each 24-hour urine collection. Results from this study will be used to assess how well the sodium excretion estimated from NHANES timed urine correlates with data from 24-hour urine collection. It will provide valuable information on the potential of NHANES timed urine collections to be used to characterize trends in U.S. population sodium intake.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study will be conducted with 400 adult volunteer participants living in the Washington DC, Maryland areas. who meet the following criteria:

Criteria

Inclusion Criteria:

English speaking

  • Aged 18-39 years old
  • 50% Black; 50% all other
  • 50% male; 50% female
  • Not pregnant or trying to get pregnant.
  • Not taking loop diuretics
  • No chronic kidney disease
  • No new hypertension treatment or change in hypertension treatment in the last 2 weeks
  • At least 50 (25 male; 25 female) of the 400 participants likely to have high sodium diet indicated by selected dietary behaviors
  • At least 50 (25 male; 25 female) of the 400 participants likely to have low sodium diet indicated by selected dietary behaviors English speaking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631240

Locations
United States, Maryland
National Center for Health Statistics, CDC, 3311 Toledo Road
Hyattsville, Maryland, United States, 20782
Sponsors and Collaborators
Centers for Disease Control and Prevention
National Institutes of Health (NIH)
Investigators
Principal Investigator: Chia-Yih Wang, PhD Centers for Disease Control and Prevention
Principal Investigator: Mary Cogswell, DrPH Centers for Disease Control and Prevention
Principal Investigator: Catherine Loria, PhD National Institutes of Health (NIH)
Principal Investigator: Christine Swanson, PhD National Institutes of Health (NIH)
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01631240     History of Changes
Other Study ID Numbers: 2011-10
Study First Received: June 11, 2012
Last Updated: June 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Sodium
Potassium
Iodine
Creatinine

ClinicalTrials.gov processed this record on June 17, 2013