NHANES Urinary Sodium Calibration Study

Nutrition Assessment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631240
• Other study ID #: 2011-10
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: July 25, 2016
• Start date: June 2011
• Est. completion date: August 2011

Study information

• Verified date: June 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Nutrition Assessment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	National Institutes of Health (NIH)

References & Publications (5)

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. — View 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 — View 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. — View 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 correla — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one day	No
Secondary	Usual potassium intake	Usual potassium intake based on 24-hour potassium excretions (two measurements for a one-third subset) using measurement error models	one day	No
Secondary	Creatinine excretion	Based on 24-hour creatinine excretion	one day	No
Secondary	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	one day	No