HypertensionNCT02723682
National Health and Nutrition Examination Survey 24-hour Urine Collection Feasibility Study, 2013
An observational study of Hypertension, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Collect 24-hour urine specimen
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: NHANES participants aged 20-69 years who were examined in the mobile examination center.
Who may be able to join
- 20-69 year old adults examined in the NHANES mobile examination center
Who cannot join
- pregnant, unable to respond for themselves
Trial locations and contacts
1 site in 1 country.
United States1 site
National Health and Nutrition Examination Survey
Hyattsville, Maryland, 20782
About this study
Official title: National Health and Nutrition Examination Survey 24-Hour Urine Collection Feasibility Study, 2013
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Collect 24-hour urine specimen
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect 24-hour urine specimenOther
A random half sample of NHANES participants 20-69 examined in the mobile examination center were asked to collect a 24-hour urine specimen.
What is being measured
The primary outcome is the main question the study is designed to answer.
Study completion rates - initial collection
Completion rate of initial 24-hour urine collection.
Measured: 24 hours
Study completion rate - second collection
Completion rate of second 24-hour urine collection
Measured: 24 hours
Secondary outcomes (6)
Response rates for the Physical Activity Monitor
Response rates for the Physical Activity Monitor
Measured: 24-hours
Response rates for the Phone Follow-up Dietary Recall
Response rates for the Phone Follow-up Dietary Recall.
Measured: 24-hours
Urine volume for the initial urine collection
Urine volume adjusted to 24 hours, initial urine collection
Measured: 24 hours
Urine volume for the second urine collection
Urine volume adjusted to 24 hours, second urine collection
Measured: 24 hours
Urinary sodium excretion for the initial urine collection
24-hour urinary sodium excretion, initial urine collection
Measured: 24 hours
Urinary sodium excretion for the second urine collection
24-hour urinary sodium excretion, second urine collection
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kathryn Porter, MD, MS, Study director, Centers for Disease Control and Prevention, National Center for Health Statistics, Division of Health and Nutrition Examination Surveys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723682
- Sponsor's protocol ID
- 2011-17
- Status last verified
- Mar 2016
- First submitted
- 8 Mar 2016
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The NHANES 24-hour urine pilot study data set can be made available through the National Center for Health Statistics Research Data Center by submitting a research proposal at http://www.cdc.gov/rdc/.
Publications
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.
PubMed 27413136
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Health and Nutrition Examination Survey 24-Hour Urine Collection Feasibility Study, 2013
- ClinicalTrials.gov ID
- NCT02723682
- Acronym / sponsor ID
- 2011-17
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NHANES participants aged 20-69 years who were examined in the mobile examination center.
Key inclusion criteria (1 listed)
- 20-69 year old adults examined in the NHANES mobile examination center
Key exclusion criteria (1 listed)
- pregnant, unable to respond for themselves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect 24-hour urine specimenA random half sample of NHANES participants 20-69 examined in the mobile examination center were asked to collect a 24-hour urine specimen. | Other | – |
Primary outcome
Study completion rates - initial collection
Time frame: 24 hours
Completion rate of initial 24-hour urine collection.
Study completion rate - second collection
Time frame: 24 hours
Completion rate of second 24-hour urine collection
6 secondary outcomes
Response rates for the Physical Activity Monitor
Time frame: 24-hours
Response rates for the Phone Follow-up Dietary Recall
Time frame: 24-hours
Urine volume for the initial urine collection
Time frame: 24 hours
Urine volume for the second urine collection
Time frame: 24 hours
Urinary sodium excretion for the initial urine collection
Time frame: 24 hours
Urinary sodium excretion for the second urine collection
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Derived from this study: PubMed 27413136Terry 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.
- Individual participant dataSharing planned: No. The NHANES 24-hour urine pilot study data set can be made available through the National Center for Health Statistics Research Data Center by submitting a research proposal at http://www.cdc.gov/rdc/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Porter, MD, MS study director
Centers for Disease Control and Prevention, National Center for Health Statistics, Division of Health and Nutrition Examination Surveys
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Centers for Disease Control and Prevention at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study completion rates - initial collection (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02723682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.