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Food Frequency Questionnaire to Assess Sodium Intake (EVALSEL)

Primary Purpose

Hypertension, Renal Insufficiency

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension focused on measuring natriuresis, Hypertension, Renal insufficiency, Sodium, Table salt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with high blood pressure, CKD stages 4-5 and patients free from any diseases
  • Patients over 18 years old
  • Patients in nephrology and cardiology consultation or recruited by CIC
  • Patients with health insurance
  • Patients willing to follow the full study

Exclusion Criteria:

  • Loss of salt by vomiting, diarrhea or sweating (intense sport or intense fever 3 days before urine collection) which can cause a decreasing natriuresis
  • Modification of the therapeutic management of patients during the study period
  • Taking certain drugs like effervescent drugs, Gaviscon and Tolvaptan during the day of urine collection, as well as diuretics (unless they are taken long-term and the diuresis is stable) which can cause an increasing natriuresis
  • Pregnant or breastfeeding women
  • Patients protected by law

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental group

    Arm Description

    patients with high blood pressure or chronic kidney diseases stages 4-5

    Outcomes

    Primary Outcome Measures

    Intra-class correlation coefficient between the quantitative measurement of sodium consumption and the 24-hour natriuresis measurement and verification of the 24-hour creatininuria values
    Intra-class correlation coefficient between the quantitative measurement of sodium consumption by the EvalSel questionnaire and the 24-hour natriuresis measurement (amount of sodium in 24-hour urine) and verification of the 24-hour creatininuria values (amount of creatinine in 24-hour urine) to confirm that the urine collection was performed correctly.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 5, 2022
    Last Updated
    September 5, 2022
    Sponsor
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05533645
    Brief Title
    Food Frequency Questionnaire to Assess Sodium Intake
    Acronym
    EVALSEL
    Official Title
    Development and Validation of a Food Frequency Questionnaire to Assess Sodium Intake in Hospitalized Patients or in Medical Consultation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    EvalSel can precisely assess the salt intake of hospitalized patients in nephrology and cardiology or in medical consultation. It can determine salt consumption to the nearest gram. The objectives of this food frequency questionnaire are to arrive at a precise dietary diagnosis and to quickly identify the dietary errors made by the patients. EvalSel is useful for doctors to quickly obtain an assessment of the salt consumption of their patients, so they can refer them to dietitians if necessary. It can be used on the day of admission to hospital or during medical follow-ups to know the evolution of their consumption over the long term and improve their care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Renal Insufficiency
    Keywords
    natriuresis, Hypertension, Renal insufficiency, Sodium, Table salt

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    99 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    patients with high blood pressure or chronic kidney diseases stages 4-5
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire
    Intervention Description
    These patients complete the food frequency questionnaire in order to validate it for lower sodium consumptions. The experimental group has already received dietary advices regarding salt consumption during during their recent consultations.
    Primary Outcome Measure Information:
    Title
    Intra-class correlation coefficient between the quantitative measurement of sodium consumption and the 24-hour natriuresis measurement and verification of the 24-hour creatininuria values
    Description
    Intra-class correlation coefficient between the quantitative measurement of sodium consumption by the EvalSel questionnaire and the 24-hour natriuresis measurement (amount of sodium in 24-hour urine) and verification of the 24-hour creatininuria values (amount of creatinine in 24-hour urine) to confirm that the urine collection was performed correctly.
    Time Frame
    through study completion an average of 18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with high blood pressure, CKD stages 4-5 and patients free from any diseases Patients over 18 years old Patients in nephrology and cardiology consultation or recruited by CIC Patients with health insurance Patients willing to follow the full study Exclusion Criteria: Loss of salt by vomiting, diarrhea or sweating (intense sport or intense fever 3 days before urine collection) which can cause a decreasing natriuresis Modification of the therapeutic management of patients during the study period Taking certain drugs like effervescent drugs, Gaviscon and Tolvaptan during the day of urine collection, as well as diuretics (unless they are taken long-term and the diuresis is stable) which can cause an increasing natriuresis Pregnant or breastfeeding women Patients protected by law
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David GUYONNET
    Phone
    0320445962
    Email
    david.guyonnet@chru-lille.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    d GUYONNET
    Organizational Affiliation
    University Hospital, Lille
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Food Frequency Questionnaire to Assess Sodium Intake

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