- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04195802
Self-administered Questionnaire to Evaluate Salt and Potassium Diet of Patients Followed in Nephrology (UniverSEL)
September 16, 2020 updated by: Hospices Civils de Lyon
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
542
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69003
- Hôpital Edouard Herriot - Service de néphrologie - HTA - Dialyse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult consulting in nephrology and having a 24h sodium urinary excretion routinely determined
Description
Inclusion Criteria:
- Adult consulting in nephrology and having a 24h sodium urinary excretion routinely determined
- Consent informed agreement
Exclusion Criteria:
- Do not want to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean Pierre FAUVEL, MD, Service de néphrologie - HTA - Dialyse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 11, 2019
Primary Completion (ACTUAL)
July 15, 2020
Study Completion (ACTUAL)
July 15, 2020
Study Registration Dates
First Submitted
December 10, 2019
First Submitted That Met QC Criteria
December 10, 2019
First Posted (ACTUAL)
December 12, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 17, 2020
Last Update Submitted That Met QC Criteria
September 16, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL69_0458
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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