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Recruiting NCT05533645

Food Frequency Questionnaire to Assess Sodium Intake

No phase Interventional Hypertension Renal Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire.
Who it may be relevant to
Registry conditions: Hypertension, Renal Insufficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Development and Validation of a Food Frequency Questionnaire to Assess Sodium Intake in Hospitalized Patients or in Medical Consultation

Overview

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.

Interventions

  • Other Questionnaire
    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 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 [Time frame: through study completion an average of 18 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Hôpital Huriez - Service Endocrinologie Diabétologie — Lille

Identifiers

NCT: NCT05533645 · 2021_0523 · 2022-A00241-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗