Cross-sectional, Non-randomized Observational Study to Assess the Frequency of Reduced Sodium Intake in the Primary Care Setting - LAXAP

Dietary Deficiency Clinical Trial

— LAXAP  

Official title:

Cross-sectional, Non-randomized Observational Study to Assess the Frequency of Reduced Sodium Intake in the Primary Care Setting - LAXAP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06121583
• Other study ID #: LAXAP-CASEN-NI 0600
• Status: Completed
• Start date: October 3, 2023
• Est. completion date: December 29, 2023

Study information

• Verified date: January 2024
• Source: Casen Recordati S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a cross-sectional epidemiological, observational study. It would be carried out in primary health care sites. The purpose of this study is estimating the percentage of patients aged 60 years or older who suffer from a condition, or take medication, associated with a low or sodium-free diet in primary care consultations.

This is a cross-sectional epidemiological study of data collection without medication.

Participants data will be collected after obtaining their confirmation through an Informed Consent From. No medication will be given to patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patients seen in the primary care unit, in person, with inclusion beginning in order of care in consultation from the beginning of the study.

• Age greater than or equal to 60 years.

Exclusion Criteria: Not applicable

Related Conditions & MeSH terms

• Dietary Deficiency
• Malnutrition
• Sodium

Locations

Country	Name	City	State
Spain	Centro de Salud Abarán	Abarán	Murcia
Spain	Centro de Salud Reyes Magos	Alcalá De Henares	Madrid
Spain	Centro de Salud Adrià	Barcelona
Spain	Centro de Salud La Barrera	Castro Urdiales	Santander
Spain	Centro de Salud Cieza Este	Cieza	Murcia
Spain	Centro de Salud Just Oliveras	Hospitalet de Llobregat	Barcelona
Spain	Consultorio Ojo de Garza	Las Palmas De Gran Canaria	Gran Canaria
Spain	Centro de Salud Avenida de Aragón	Madrid
Spain	Centro de Salud Daroca	Madrid
Spain	Centro de Salud Goya	Madrid
Spain	Centro de Salud Potes	Madrid
Spain	Centro de Salud Gracia Sabadell	Sabadell	Barcelona
Spain	Centro de Salud Dr. Guigou	Santa Cruz De Tenerife	Tenerife
Spain	Centro de Salud Icod de los Vinos	Santa Cruz De Tenerife	Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Casen Recordati S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who suffer from a condition or take medication associated with a diet low or absent of sodium.	Patients who require to follow a diet with low sodium content defined as patients that suffer from a condition or take medication associated with a diet low or absent of sodium: Right or congestive heart failure, Acute kidney failure, Chronic renal failure, Nephrotic syndrome, Edematogenic glomerulonephritis, Diabetic nephropathy, Nephrolithiasis, Arterial hypertension, Ascites, Hepatic cirrhosis, Prolonged treatments (more than 6 months) with corticosteroids	At the time of the consultation, anticipated average 1 hour
Secondary	Percentage of patients who present a recommendation/prescription for a low-sodium diet.		At the time of the consultation, anticipated average 1 hour
Secondary	Percentage of patients with constipation	Constipation according to Rome III: a diagnosis of functional constipation is made when at least two of the following criteria are met for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) straining on >25% of defecations; b) lumpy or hard stools on >25% of defecations; c) sensation of incomplete evacuation on >25% of defecations; d) sensation of anorectal obstruction/blockage on >25% of defecations; e) manual maneuvers on >25% of defecations; and f) less than 3 defecations per week.	At the time of the consultation, anticipated average 1 hour
Secondary	Percentage of patients who take laxatives		At the time of the consultation, anticipated average 1 hour
Secondary	Percentage of patients who present constipation and suffer from a condition or take medication associated with a diet low or absent of sodium.	Constipation according to Rome III: a diagnosis of functional constipation is made when at least two of the following criteria are met for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) straining on >25% of defecations; b) lumpy or hard stools on >25% of defecations; c) sensation of incomplete evacuation on >25% of defecations; d) sensation of anorectal obstruction/blockage on >25% of defecations; e) manual maneuvers on >25% of defecations; and f) less than 3 defecations per week.; Patients who require to follow a diet with low sodium content defined as patients that suffer from a condition or take medication associated with a diet low or absent of sodium: Right or congestive heart failure, Acute kidney failure, Chronic renal failure, Nephrotic syndrome, Edematogenic glomerulonephritis, Diabetic nephropathy, Nephrolithiasis, Arterial hypertension, Ascites, Hepatic cirrhosis, Prolonged treatments (more than 6 months) with corticosteroids	At the time of the consultation, anticipated average 1 hour
Secondary	Percentage of patients who present constipation and suffer from a condition or take a medication associated with a low or absent sodium diet and receive a prescription for a laxative with a high level of sodium	Constipation according to Rome III: a diagnosis of functional constipation is made when at least two of the following criteria are met for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) straining on >25% of defecations; b) lumpy or hard stools on >25% of defecations; c) sensation of incomplete evacuation on >25% of defecations; d) sensation of anorectal obstruction/blockage on >25% of defecations; e) manual maneuvers on >25% of defecations; and f) less than 3 defecations per week.; Patients who require to follow a diet with low sodium content defined as patients that suffer from a condition or take medication associated with a diet low or absent of sodium: Right or congestive heart failure, Acute kidney failure, Chronic renal failure, Nephrotic syndrome, Edematogenic glomerulonephritis, Diabetic nephropathy, Nephrolithiasis, Arterial hypertension, Ascites, Hepatic cirrhosis, Prolonged treatments (more than 6 months) with corticosteroids	At the time of the consultation, anticipated average 1 hour
Secondary	Percentage of patients with each of the diseases or taking treatments that recommend the intake of a diet with low sodium content.	Patients that suffer from a condition or take medication associated with a diet low or absent of sodium: Right or congestive heart failure, Acute kidney failure, Chronic renal failure, Nephrotic syndrome, Edematogenic glomerulonephritis, Diabetic nephropathy, Nephrolithiasis, Arterial hypertension, Ascites, Hepatic cirrhosis, Prolonged treatments (more than 6 months) with corticosteroids	At the time of the consultation, anticipated average 1 hour
Secondary	Percentage of patients who have sodium restriction in the diet and receive sodium in the form of concomitant medication.		At the time of the consultation, anticipated average 1 hour
Secondary	Description of each of the study populations	Description of patients who suffer from a condition or take a medication associated with a low or no sodium diet, patients with a low sodium diet recommendation, patients with constipation, patients taking laxatives: Data demographics, anthropometric data, diseases associated with a low sodium diet, constipation, laxatives and concomitant medication. In terms of their demographics and clinical characteristics.	At the time of the consultation, anticipated average 1 hour
Secondary	Percentage of patients with concomitant medication that may affect the amount of sodium in the blood by type, dosage, duration of treatment		At the time of the consultation, anticipated average 1 hour