Food Frequency Questionnaire to Assess Sodium Intake

Hypertension Clinical Trial

— EVALSEL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05533645
• Other study ID #: 2021_0523
• Secondary ID: 2022-A00241-42
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: August 2024

Study information

• Verified date: September 2022
• Source: University Hospital, Lille
• Contact: David GUYONNET
• Phone: 0320445962
• Email: david.guyonnet[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 99
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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