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CompletedNCT01631240Updated Jul 26, 2016

NHANES Urinary Sodium Calibration Study

An observational study in Nutrition Assessment, sponsored by Centers for Disease Control and Prevention. Completed. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-26.

Sponsored by Centers for Disease Control and Prevention · Observational

Study type
Observational
Time perspective
Cross-sectional
Enrollment
441
Ages
18 Years to 39 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Nutrition Assessment

Keywords

  • Sodium
  • Potassium
  • Iodine
  • Creatinine
03

In context

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
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:

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

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
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Study design

Time perspective
Cross-sectional
Enrollment
441 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Adults 18-39 years

    Healthy adults aged 18-39 years

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What researchers measure

Primary outcomes

  1. Usual sodium intake

    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

    Time frame: one day

Secondary outcomes

  1. Usual potassium intake

    Usual potassium intake based on 24-hour potassium excretions (two measurements for a one-third subset) using measurement error models

    Time frame: one day

  2. Creatinine excretion

    Based on 24-hour creatinine excretion

    Time frame: one day

  3. Usual iodine intake

    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

    Time frame: one day

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Wang CY, Carriquiry AL, Chen TC, Loria CM, Pfeiffer CM, Liu K, Sempos CT, Perrine CG, Cogswell ME. Estimating the population distribution of usual 24-hour sodium excretion from timed urine void specimens using a statistical approach accounting for correlated measurement errors. J Nutr. 2015 May;145(5):1017-24. doi: 10.3945/jn.114.206250. Epub 2015 Apr 1. PubMed 25833885 ↗
  • Mercado CI, Cogswell ME, Valderrama AL, Wang CY, Loria CM, Moshfegh AJ, Rhodes DG, Carriquiry AL. Difference between 24-h diet recall and urine excretion for assessing population sodium and potassium intake in adults aged 18-39 y. Am J Clin Nutr. 2015 Feb;101(2):376-86. doi: 10.3945/ajcn.113.081604. Epub 2014 Dec 17. PubMed 25646336 ↗
  • Perrine CG, Cogswell ME, Swanson CA, Sullivan KM, Chen TC, Carriquiry AL, Dodd KW, Caldwell KL, Wang CY. Comparison of population iodine estimates from 24-hour urine and timed-spot urine samples. Thyroid. 2014 Apr;24(4):748-57. doi: 10.1089/thy.2013.0404. Epub 2014 Mar 4. PubMed 24308769 ↗
  • Cogswell ME, Wang CY, Chen TC, Pfeiffer CM, Elliott P, Gillespie CD, Carriquiry AL, Sempos CT, Liu K, Perrine CG, Swanson CA, Caldwell KL, Loria CM. Validity of predictive equations for 24-h urinary sodium excretion in adults aged 18-39 y. Am J Clin Nutr. 2013 Dec;98(6):1502-13. doi: 10.3945/ajcn.113.059436. Epub 2013 Sep 18. PubMed 24047921 ↗
  • Wang CY, Cogswell ME, Loria CM, Chen TC, Pfeiffer CM, Swanson CA, Caldwell KL, Perrine CG, Carriquiry AL, Liu K, Sempos CT, Gillespie CD, Burt VL. Urinary excretion of sodium, potassium, and chloride, but not iodine, varies by timing of collection in a 24-hour calibration study. J Nutr. 2013 Aug;143(8):1276-82. doi: 10.3945/jn.113.175927. Epub 2013 Jun 12. PubMed 23761643 ↗

Individual participant data

Plan to share: Yes — Data are available through the NCHS Research Data Center

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01631240
Lead sponsor
Centers for Disease Control and Prevention
Collaborators
National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Jun 29, 2012
Start date
Jun 2011
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Jul 26, 2016

Study contacts

Chia-Yih Wang, PhD
principal investigator · Centers for Disease Control and Prevention
Mary Cogswell, DrPH
principal investigator · Centers for Disease Control and Prevention
Catherine Loria, PhD
principal investigator · National Institutes of Health (NIH)
Christine Swanson, PhD
principal investigator · National Institutes of Health (NIH)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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