Clinical trial NCT01631240: NHANES Urinary Sodium Calibration Study
Official title: National Health and Nutrition Examination Survey (NHANES), Urinary Sodium Calibration Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition Assessment
Keywords: Sodium
Potassium
Iodine
Creatinine
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: National Institutes of Health (NIH)
First posted: 2012-06-29
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
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:

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.

Eligibility 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

Primary outcomes:
measure: Usual sodium intake
timeFrame: one day
Secondary outcomes:
measure: Usual potassium intake
timeFrame: one day
measure: Creatinine excretion
timeFrame: one day
measure: Usual iodine intake
timeFrame: one day
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Chia-Yih Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Mary Cogswell, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institutes of Health (NIH)
name: Catherine Loria, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institutes of Health (NIH)
name: Christine Swanson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.