Nephropathy, Chronic TubulointerstitialUniverSELNCT04195802
Self-administered Questionnaire to Evaluate Salt and Potassium Diet of Patients Followed in Nephrology
An observational study of Nephropathy, Chronic Tubulointerstitial, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The aim of the study is to create a self-questionnaire to evaluate sodium and potassium diet in chronic kidney disease patients. Questionnaires will be compared to 24h sodium and potassium urinary excretion (reference) A Bayesian network and a multiple regression will be used to select the most relevant items Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephropathy, Chronic Tubulointerstitial
- What is being tested?
- Salt and potassium Diet
- How many people
- 542 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2019to 15 Jul 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult consulting in nephrology and having a 24h sodium urinary excretion routinely determined
Who may be able to join
- Adult consulting in nephrology and having a 24h sodium urinary excretion routinely determined
- Consent informed agreement
Who cannot join
- Do not want to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Edouard Herriot - Service de néphrologie - HTA - Dialyse
Lyon, 69003
About this study
Official title: Self-administered Questionnaire to Evaluate Salt and Potassium Diet of Patients Followed in Nephrology - UniverSEL Study
The aim of the study is to create a self-questionnaire to evaluate sodium and potassium diet in chronic kidney disease patients.
Questionnaires will be compared to 24h sodium and potassium urinary excretion (reference) A Bayesian network and a multiple regression will be used to select the most relevant items
- Conditions
- Nephropathy, Chronic Tubulointerstitial
- Being tested
- Salt and potassium Diet
- Medical subject headings
- Nephropathy, Chronic Tubulointerstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt and potassium DietOther
Self-administration questionnary to evaluate the salt and potassium consumption
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of the study is to create a self-administered questionnaire to evaluate sodium and potassium consumption in chronic kidney disease patients.
comparison of answers to the self-questionnaire about salt and potassium diet with natriuresis and kaliuresis urinary excretion during 24 hours
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start11 Oct 2019
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephropathy, Chronic TubulointerstitialStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Pierre FAUVEL, MD, Principal investigator, Service de néphrologie - HTA - Dialyse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195802
- Sponsor's protocol ID
- 69HCL69_0458
- Acronym
- UniverSEL
- Status last verified
- Sep 2020
- First submitted
- 10 Dec 2019
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-administered Questionnaire to Evaluate Salt and Potassium Diet of Patients Followed in Nephrology - UniverSEL Study
- ClinicalTrials.gov ID
- NCT04195802
- Acronym / sponsor ID
- UniverSEL / 69HCL69_0458
- Conditions
- Nephropathy, Chronic Tubulointerstitial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 12 Dec 2019 (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.
The aim of the study is to create a self-questionnaire to evaluate sodium and potassium diet in chronic kidney disease patients.
Questionnaires will be compared to 24h sodium and potassium urinary excretion (reference) A Bayesian network and a multiple regression will be used to select the most relevant items
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult consulting in nephrology and having a 24h sodium urinary excretion routinely determined
Key inclusion criteria (2 listed)
- Adult consulting in nephrology and having a 24h sodium urinary excretion routinely determined
- Consent informed agreement
Key exclusion criteria (1 listed)
- Do not want to participate
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 |
|---|---|---|
| Salt and potassium DietSelf-administration questionnary to evaluate the salt and potassium consumption | Other | – |
Primary outcome
The aim of the study is to create a self-administered questionnaire to evaluate sodium and potassium consumption in chronic kidney disease patients.
Time frame: at inclusion
comparison of answers to the self-questionnaire about salt and potassium diet with natriuresis and kaliuresis urinary excretion during 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 17 Sep 2020.
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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.
Jean Pierre FAUVEL, MD principal investigator
Service de néphrologie - HTA - Dialyse
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 Nephropathy, Chronic Tubulointerstitial, run by Hospices Civils de Lyon at 1 site in France.
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 2 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 17 Sep 2020. 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 France. 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?
The aim of the study is to create a self-administered questionnaire to evaluate sodium and potassium consumption in chronic kidney disease patients. (time frame: at inclusion). 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 17 Sep 2020.