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NHANES Urinary Sodium Calibration Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01631240
Enrollment
441
Registered
2012-06-29
Start date
2011-06-30
Completion date
2011-08-31
Last updated
2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition Assessment

Keywords

Sodium, Potassium, Iodine, Creatinine

Brief summary

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

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.

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Usual sodium intakeone dayUsual 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

MeasureTime frameDescription
Usual potassium intakeone dayUsual potassium intake based on 24-hour potassium excretions (two measurements for a one-third subset) using measurement error models
Creatinine excretionone dayBased on 24-hour creatinine excretion
Usual iodine intakeone dayUsual 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026