NCT01631240

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
441

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
Last Updated

July 26, 2016

Status Verified

June 1, 2012

Enrollment Period

2 months

First QC Date

June 11, 2012

Last Update Submit

July 25, 2016

Conditions

Nutrition Assessment

Keywords

SodiumPotassiumIodineCreatinine

Outcome Measures

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

    one day

Secondary Outcomes (3)

  • Usual potassium intake

    one day

  • Creatinine excretion

    one day

  • Usual iodine intake

    one day

Study Arms (1)

Adults 18-39 years

Healthy adults aged 18-39 years

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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:

You may qualify if:

  • English speaking
  • Aged 18-39 years old
  • % Black; 50% all other
  • % 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 25833885RESULT

  • 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.

    PMID: 25646336RESULT

  • 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.

    PMID: 24308769RESULT

  • 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.

    PMID: 24047921RESULT

  • 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.

    PMID: 23761643RESULT

  • Freedman LS, Wang CY, Commins J, Barrett B, Midthune D, Dodd KW, Carroll RJ, Kipnis V. Can sodium and potassium measured in timed voids be used as reference instruments for validating self-report instruments? Results from a urine calibration study. Am J Clin Nutr. 2024 May;119(5):1321-1328. doi: 10.1016/j.ajcnut.2024.02.013. Epub 2024 Feb 23.

    PMID: 38403166DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine specimens

Study Officials

  • Chia-Yih Wang, PhD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Mary Cogswell, DrPH

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Catherine Loria, PhD

    National Institutes of Health (NIH)

    PRINCIPAL INVESTIGATOR

  • Christine Swanson, PhD

    National Institutes of Health (NIH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 29, 2012

Study Start

June 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 26, 2016

Record last verified: 2012-06

Data Sharing

IPD Sharing
Will share

Data are available through the NCHS Research Data Center