NHANES Urinary Sodium Calibration Study

July 25, 2016 updated by: Centers for Disease Control and Prevention

National Health and Nutrition Examination Survey (NHANES), Urinary Sodium Calibration Study

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

441

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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:

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adults 18-39 years
Healthy adults aged 18-39 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usual sodium intake
Time Frame: one day
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
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usual potassium intake
Time Frame: one day
Usual potassium intake based on 24-hour potassium excretions (two measurements for a one-third subset) using measurement error models
one day
Creatinine excretion
Time Frame: one day
Based on 24-hour creatinine excretion
one day
Usual iodine intake
Time Frame: one day
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
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2011-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data are available through the NCHS Research Data Center

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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