Clinical trial NCT02723682: National Health and Nutrition Examination Survey 24-hour Urine Collection Feasibility Study, 2013
Official title: National Health and Nutrition Examination Survey 24-Hour Urine Collection Feasibility Study, 2013
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-03-30
Enrollment: 282
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: NHANES participants aged 20-69 years who were examined in the mobile examination center.

Brief summary: A 24-hour urine pilot study was conducted as part of the 2013 NHANES to test the feasibility of implementing a 24-hour urine collection as part of NHANES in 2014.

Detailed description: The 24-hour urine pilot study was conducted March - June 2013 in three NHANES locations. A random half-sample of non-pregnant US adults, aged 20-69 who were examined in the NHANES mobile examination center were selected. Participants received instructions, started and ended the urine collection in a urine study mobile examination center (UMEC), and answered questions about collection. A random half of participants who collected a complete 24-h urine were asked to collect a second 24-h urine. Urinary sodium, potassium, chloride, and creatinine excretion were analyzed.

Participation rates in two other post-examination components, the Physical Activity Monitor and the Dietary Recall, were monitored to determine whether collecting a 24-hour urine had an effect on response rates for the two components.

Eligibility criteria: Inclusion Criteria:

* 20-69 year old adults examined in the NHANES mobile examination center

Exclusion Criteria:

* pregnant, unable to respond for themselves

Primary outcomes:
measure: Study completion rates - initial collection
timeFrame: 24 hours
measure: Study completion rate - second collection
timeFrame: 24 hours
Secondary outcomes:
measure: Response rates for the Physical Activity Monitor
timeFrame: 24-hours
measure: Response rates for the Phone Follow-up Dietary Recall
timeFrame: 24-hours
measure: Urine volume for the initial urine collection
timeFrame: 24 hours
measure: Urine volume for the second urine collection
timeFrame: 24 hours
measure: Urinary sodium excretion for the initial urine collection
timeFrame: 24 hours
measure: Urinary sodium excretion for the second urine collection
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hyattsville
country: United States
facility: National Health and Nutrition Examination Survey
state: Maryland
Study officials:
affiliation: Centers for Disease Control and Prevention, National Center for Health Statistics, Division of Health and Nutrition Examination Surveys
name: Kathryn Porter, MD, MS
role: STUDY_DIRECTOR
References:
citation: Terry AL, Cogswell ME, Wang CY, Chen TC, Loria CM, Wright JD, Zhang X, Lacher DA, Merritt RK, Bowman BA. Feasibility of collecting 24-h urine to monitor sodium intake in the National Health and Nutrition Examination Survey. Am J Clin Nutr. 2016 Aug;104(2):480-8. doi: 10.3945/ajcn.115.121954. Epub 2016 Jul 13.