UniverSEL: Self-administered Questionnaire to Evaluate Salt and Potassium Diet of Patients Followed in Nephrology

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT04195802
• Collaborator: (none)
• Enrollment: 542
• Location: 1
• Actual Duration (Months): 9.1
• Patients Per Site Per Month: 59.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Nephropathy, Chronic Tubulointerstitial	Other: Salt and potassium Diet

Study Design

• Study Type: Observational
• Actual Enrollment: 542 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Self-administered Questionnaire to Evaluate Salt and Potassium Diet of Patients Followed in Nephrology - UniverSEL Study
• Actual Study Start Date: Oct 11, 2019
• Actual Primary Completion Date: Jul 15, 2020
• Actual Study Completion Date: Jul 15, 2020

Outcome Measures

Primary Outcome Measures

1. The aim of the study is to create a self-administered questionnaire to evaluate sodium and potassium consumption in chronic kidney disease patients. [at inclusion]

   comparison of answers to the self-questionnaire about salt and potassium diet with natriuresis and kaliuresis urinary excretion during 24 hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Edouard Herriot - Service de néphrologie - HTA - Dialyse	Lyon		France	69003

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

• Principal Investigator: Jean Pierre FAUVEL, MD, Service de néphrologie - HTA - Dialyse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT04195802
• Other Study ID Numbers: 69HCL69_0458
• First Posted: Dec 12, 2019
• Last Update Posted: Sep 17, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Nephritis, Interstitial

Study Results

No Results Posted as of Sep 17, 2020