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Completed

NCT Number: NCT01631240

NHANES Urinary Sodium Calibration Study

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

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Usual sodium intake

    Time frame: 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 outcomes

  1. Usual potassium intake

    Time frame: one day

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

  2. Creatinine excretion

    Time frame: one day

    Based on 24-hour creatinine excretion

  3. Usual iodine intake

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 29, 2012
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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