Dietary HabitsNCT03154502
Sodium Intake in Ecuadorian Population
An observational study of Dietary Habits and Risk Factor, Cardiovascular, run by Universidad San Francisco de Quito.
Trial summary
This study is aim to determine the sodium intake in Ecuadorian population that is an unknown information at present. For that, 24h urine samples will be collected from 130 subjects working either at tue USFQ or HDLV to measure sodium excretion. Read more about this study
- Who is it for?
- Ages 25 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Risk Factor, Cardiovascular, Nutritional Disorder
- What is being tested?
- Urinary sodium excretion
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 30 Oct 2016
- 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 25 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Will be enrolled a sample of 178 adults aged 25 to 64 years. The research team, who have faculty appointments in USFQ, supervised the collection of the urine samples. We invited a broad spectrum of employees (which included health care workers, professors, and custodial staff) from both institutions to participate in the study.
Who may be able to join
- None
Who cannot join
- unable to provide informed consent
- unable to provide 24-hr urine excretion sample
- those with a known history of heart or kidney failure, stroke, and liver disease
- those using diuretics, multivitamins, NSADs, or prostaglandins during the last two weeks
- pregnant women
About this study
Official title: Sodium Urinary Excretion Measurement in Ecuadorian Population
This study is aim to determine the sodium intake in Ecuadorian population that is an unknown information at present. For that, 24h urine samples will be collected from 130 subjects working either at tue USFQ or HDLV to measure sodium excretion.
- Being tested
- Urinary sodium excretion
- Keywords
- Sodium intake, Urinary sodium excretion
- Medical subject headings
- Feeding Behavior, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary sodium excretionDiagnostic test
Urinary sodium and potassium were measured using the Ion-Selective Electrode (ISE) indirect Na-K-Cl for Gen.2 (Roche Diagnostic, Switzerland).
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary sodium excretion
Amount of sodium in 24h urine collection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Mar 2015
- Primary completion30 Oct 2016
- Study completion30 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Francisco de Quito
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Sisa, Universidad San Francisco de Quito
- Investigators
- Enrique Teran, MD, PhD, Study director, Universidad San Francisco de Quito
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154502
- Sponsor's protocol ID
- HUBI-1022
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Urinary Excretion Measurement in Ecuadorian Population
- ClinicalTrials.gov ID
- NCT03154502
- Acronym / sponsor ID
- HUBI-1022
- Keywords
- Sodium intake, Urinary sodium excretion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Universidad San Francisco de QuitoUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 16 May 2017 (actual)
- 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 study is aim to determine the sodium intake in Ecuadorian population that is an unknown information at present. For that, 24h urine samples will be collected from 130 subjects working either at tue USFQ or HDLV to measure sodium excretion.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Will be enrolled a sample of 178 adults aged 25 to 64 years. The research team, who have faculty appointments in USFQ, supervised the collection of the urine samples. We invited a broad spectrum of employees (which included health care workers, professors, and custodial staff) from both institutions to participate in the study.
Key inclusion criteria (1 listed)
- None
Key exclusion criteria (5 listed)
- unable to provide informed consent
- unable to provide 24-hr urine excretion sample
- those with a known history of heart or kidney failure, stroke, and liver disease
- those using diuretics, multivitamins, NSADs, or prostaglandins during the last two weeks
- pregnant women
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 |
|---|---|---|
| Urinary sodium excretionUrinary sodium and potassium were measured using the Ion-Selective Electrode (ISE) indirect Na-K-Cl for Gen.2 (Roche Diagnostic, Switzerland). | Diagnostic test | – |
Primary outcome
Urinary sodium excretion
Time frame: 1 year
Amount of sodium in 24h urine collection
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 16 May 2017.
- Individual participant dataSharing planned: No
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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.
Enrique Teran, MD, PhD study director
Universidad San Francisco de Quito
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Habits and Risk Factor, Cardiovascular, run by Universidad San Francisco de Quito.
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 5 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 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Urinary sodium excretion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2017.