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: July 25, 2016
Last verified: June 2012
  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
Nutrition Assessment

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:


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   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study was conducted with 407 adult volunteer participants living in the Washington DC, Maryland areas who met the following criteria:
Criteria

Inclusion Criteria:

English speaking

  • Aged 18-39 years old
  • 50% Black; 50% all other
  • 50% male; 50% female
  • 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

Exclusion Criteria:

  • Pregnant or trying to get pregnant.
  • Taking loop diuretics
  • Chronic kidney disease
  • New hypertension treatment or change in hypertension treatment in the last 2 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631240

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

Publications:

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: July 25, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Data are available through the NCHS Research Data Center

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

ClinicalTrials.gov processed this record on July 26, 2016