NHANES Urinary Sodium Calibration Study

Completed

• Conditions: Nutrition Assessment

• Registration Number: NCT01631240
• Lead Sponsor: Centers for Disease Control and Prevention

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-06
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-29
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Usual sodium intake	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

Secondary Outcome Measures

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