Food Frequency Questionnaire to Assess Sodium Intake

NCT05533645 | Recruiting

• 2 other identifiers: 2021_05232022-A00241-42
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Renal Insufficiency

Keywords

natriuresis; Hypertension; Renal insufficiency; Sodium; Table salt

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion an average of 18 months

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Other: Questionnaire

Interventions

Questionnaire OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Huriez - Service Endocrinologie Diabétologie

Lille, France

RECRUITING

MeSH Terms

Conditions

Hypertension; Renal Insufficiency

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• d GUYONNET

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David GUYONNET

CONTACT

0320445962; david.guyonnet@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 9, 2022
• Study Start: June 6, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)