Self-administered Questionnaire to Evaluate Salt and Pota... | NCT04195802

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

NCT04195802

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Sep 17, 2020Actual

Enrollment

542Actual

Phase

Not provided

Conditions

Nephropathy, Chronic Tubulointerstitial

Interventions

Salt and potassium Diet

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 11, 2019Actual

Primary Completion Date

Jul 15, 2020Actual

Completion Date

Jul 15, 2020Actual

First Submitted Date

Dec 10, 2019

First Submission Date that Met QC Criteria

Dec 10, 2019

First Posted Date

Dec 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2020

Last Update Posted Date

Sep 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

542Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Salt and potassium Diet	Other	Self-administration questionnary to evaluate the salt and potassium consumption

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult consulting in nephrology and having a 24h sodium urinary excretion routinely determined

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean Pierre FAUVEL, MD	Service de néphrologie - HTA - Dialyse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Edouard Herriot - Service de néphrologie - HTA - Dialyse		Lyon		69003	France

Condition Browse Module

MeSH Terms

ID	Term
C564016	Nephropathy, Chronic Tubulointerstitial

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided