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NCT Number: NCT06121583

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

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.

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Key information

Conditions

Dietary Deficiency Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Sodium

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro de Salud Just Oliveras, L'Hospitalet de Llobregat, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of patients who suffer from a condition or take medication associated with a diet low or absent of sodium.

    Time frame: At the time of the consultation, anticipated average 1 hour

    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

Secondary outcomes

  1. Percentage of patients who present a recommendation/prescription for a low-sodium diet.

    Time frame: At the time of the consultation, anticipated average 1 hour

  2. Percentage of patients with constipation

    Time frame: At the time of the consultation, anticipated average 1 hour

    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.

  3. Percentage of patients who take laxatives

    Time frame: At the time of the consultation, anticipated average 1 hour

  4. Percentage of patients who present constipation and suffer from a condition or take medication associated with a diet low or absent of sodium.

    Time frame: At the time of the consultation, anticipated average 1 hour

    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

  5. 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

    Time frame: At the time of the consultation, anticipated average 1 hour

    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

  6. Percentage of patients with each of the diseases or taking treatments that recommend the intake of a diet with low sodium content.

    Time frame: At the time of the consultation, anticipated average 1 hour

    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

  7. Percentage of patients who have sodium restriction in the diet and receive sodium in the form of concomitant medication.

    Time frame: At the time of the consultation, anticipated average 1 hour

  8. Description of each of the study populations

    Time frame: At the time of the consultation, anticipated average 1 hour

    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.

  9. Percentage of patients with concomitant medication that may affect the amount of sodium in the blood by type, dosage, duration of treatment

    Time frame: At the time of the consultation, anticipated average 1 hour

Sponsors and collaborators

Lead sponsor

Casen Recordati S.L.

Industry

Registry information

Acronym: LAXAP

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2023
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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