SodiumHFUSNCT01889589
NYC Heart Follow-Up Study 2010
An observational study of Sodium, run by New York City Department of Health and Mental Hygiene at 1 site in United States.
Trial summary
This surveillance project will assess NYC population sodium intake using the gold standard measurement of 24-hour urine collection. This surveillance project is a critical component of a larger initiative, coordinated by NYC, to reduce sodium intake nationwide through voluntary industry reductions in processed food… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sodium
- What is being tested?
- Surveillance
- How many people
- 1,775 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: NYC adult population
Who may be able to join
- > 18 Years
Who cannot join
- Pregnant, breastfeeding or lactating; past or current dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Baseline 24 Hour Urine Collection in Population-based Sample of NYC Adults
This surveillance project will assess NYC population sodium intake using the gold standard measurement of 24-hour urine collection. This surveillance project is a critical component of a larger initiative, coordinated by NYC, to reduce sodium intake nationwide through voluntary industry reductions in processed food sodium content. The project will assess current population sodium intake, against which population intake changes at three years can be assessed
- Conditions
- Sodium
- Being tested
- Surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveillanceOther
| Study group | Role | What they receive |
|---|---|---|
| NYC adults | Not described Receives: Other: Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urinary sodium
Measured: 24-hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SodiumStudies 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
- 1,775 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York City Department of Health and Mental Hygiene
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Stella Yi, New York City Department of Health and Mental Hygiene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889589
- Sponsor's protocol ID
- NYCHFUS2010
- Acronym
- HFUS
- Status last verified
- Jun 2013
- First submitted
- 26 Jun 2013
- Last updated
- 28 Jun 2013
- Results posted
- No
Publications
Elfassy T, Yi SS, Llabre MM, Schneiderman N, Gellman M, Florez H, Prado G, Zeki Al Hazzouri A. Neighbourhood socioeconomic status and cross-sectional associations with obesity and urinary biomarkers of diet among New York City adults: the heart follow-up study. BMJ Open. 2017 Dec 29;7(12):e018566. doi: 10.1136/bmjopen-2017-018566.
PubMed 29289939Loftfield E, Yi S, Curtis CJ, Bartley K, Kansagra SM. Potassium and fruit and vegetable intakes in relation to social determinants and access to produce in New York City. Am J Clin Nutr. 2013 Nov;98(5):1282-8. doi: 10.3945/ajcn.113.059204. Epub 2013 Sep 11.
PubMed 24025631
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline 24 Hour Urine Collection in Population-based Sample of NYC Adults
- ClinicalTrials.gov ID
- NCT01889589
- Acronym / sponsor ID
- HFUS / NYCHFUS2010
- Conditions
- Sodium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,775 participants (actual)
- Lead sponsor
- New York City Department of Health and Mental HygieneOther government
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Jun 2013 (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.
This surveillance project will assess NYC population sodium intake using the gold standard measurement of 24-hour urine collection. This surveillance project is a critical component of a larger initiative, coordinated by NYC, to reduce sodium intake nationwide through voluntary industry reductions in processed food sodium content. The project will assess current population sodium intake, against which population intake changes at three years can be assessed
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NYC adults | – | Other: Surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NYC adult population
Key inclusion criteria (1 listed)
- > 18 Years
Key exclusion criteria (1 listed)
- Pregnant, breastfeeding or lactating; past or current dialysis
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 |
|---|---|---|
| Surveillance | Other | NYC adults |
Primary outcome
24-hour urinary sodium
Time frame: 24-hour period
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 28 Jun 2013.
- Derived from this study: PubMed 29289939Elfassy T, Yi SS, Llabre MM, Schneiderman N, Gellman M, Florez H, Prado G, Zeki Al Hazzouri A. Neighbourhood socioeconomic status and cross-sectional associations with obesity and urinary biomarkers of diet among New York City adults: the heart follow-up study. BMJ Open. 2017 Dec 29;7(12):e018566. doi: 10.1136/bmjopen-2017-018566.
- Derived from this study: PubMed 24025631Loftfield E, Yi S, Curtis CJ, Bartley K, Kansagra SM. Potassium and fruit and vegetable intakes in relation to social determinants and access to produce in New York City. Am J Clin Nutr. 2013 Nov;98(5):1282-8. doi: 10.3945/ajcn.113.059204. Epub 2013 Sep 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sodium, run by New York City Department of Health and Mental Hygiene 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 28 Jun 2013. 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?
24-hour urinary sodium (time frame: 24-hour period). 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 NCT01889589, which also lists 2 linked publications.
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 28 Jun 2013.