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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06121583
Acronym
LAXAP
Enrollment
449
Registered
2023-11-08
Start date
2023-10-03
Completion date
2023-12-29
Last updated
2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Deficiency, Sodium

Brief 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.

Interventions

None listed

Sponsors

Casen Recordati S.L.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients who suffer from a condition or take medication associated with a diet low or absent of sodium.At the time of the consultation, anticipated average 1 hourPatients 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

Secondary

MeasureTime frameDescription
Percentage of patients with constipationAt the time of the consultation, anticipated average 1 hourConstipation 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.
Percentage of patients who take laxativesAt the time of the consultation, anticipated average 1 hour
Percentage of patients who present constipation and suffer from a condition or take medication associated with a diet low or absent of sodium.At the time of the consultation, anticipated average 1 hourConstipation 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
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 sodiumAt the time of the consultation, anticipated average 1 hourConstipation 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
Percentage of patients who present a recommendation/prescription for a low-sodium diet.At the time of the consultation, anticipated average 1 hour
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
Description of each of the study populationsAt the time of the consultation, anticipated average 1 hourDescription 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.
Percentage of patients with concomitant medication that may affect the amount of sodium in the blood by type, dosage, duration of treatmentAt the time of the consultation, anticipated average 1 hour
Percentage of patients with each of the diseases or taking treatments that recommend the intake of a diet with low sodium content.At the time of the consultation, anticipated average 1 hourPatients 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026