Food Frequency Questionnaire to Assess Sodium Intake

Not Applicable

Not yet recruiting

• Conditions: Renal Insufficiency; Hypertension
• Interventions: Other: Questionnaire

• Registration Number: NCT05533645
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-05
• Study First Submitted QC: 2022-09-05
• Last Update Submitted: 2022-09-05
• Study First Posted: 2022-09-09
• Last Update Posted: 2022-09-09
• Study Start: 2023-02
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Questionnaire	patients with high blood pressure or chronic kidney diseases stages 4-5

Primary Outcome Measures

Name	Time	Method
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	through study completion an average of 18 months	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.