Dietary DeficiencyLAXAPNCT06121583
Cross-sectional, Non-randomized Observational Study to Assess the Frequency of Reduced Sodium Intake in the Primary Care Setting - LAXAP
An observational study of Dietary Deficiency and Sodium, run by Casen Recordati S.L. at 14 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Deficiency, Sodium
- How many people
- 449 participants
- Where
- 14 sitesSpain
- Study dates
- 3 Oct 2023to 29 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (over 60 years of age or older) who attend primary care units
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Centro de Salud Abarán
Abarán, Murcia
Centro de Salud Reyes Magos
Alcalá de Henares, Madrid
Centro de Salud Adrià
Barcelona
Centro de Salud La Barrera
Castro Urdiales, Cantabria
Centro de Salud Cieza Este
Cieza, Murcia
Centro de Salud Just Oliveras
L'Hospitalet de Llobregat, Barcelona
Consultorio Ojo de Garza
Las Palmas de Gran Canaria, Gran Canaria
Centro de Salud Avenida de Aragón
Madrid
Centro de Salud Daroca
Madrid
Centro de Salud Goya
Madrid
Centro de Salud Potes
Madrid
Centro de Salud Gracia Sabadell
Sabadell, Barcelona
Centro de Salud Dr. Guigou
Santa Cruz de Tenerife, Tenerife
Centro de Salud Icod de los Vinos
Santa Cruz de Tenerife, Tenerife
About this study
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.
- Conditions
- Dietary Deficiency, Sodium
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the time of the consultation, anticipated average 1 hour
Secondary outcomes (9)
Percentage of patients who present a recommendation/prescription for a low-sodium diet.
Measured: At the time of the consultation, anticipated average 1 hour
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.
Measured: At the time of the consultation, anticipated average 1 hour
Percentage of patients who take laxatives
Measured: At 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.
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
Measured: At the time of the consultation, anticipated average 1 hour
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
Measured: At 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.
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
Measured: 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.
Measured: At the time of the consultation, anticipated average 1 hour
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.
Measured: At the time of the consultation, anticipated average 1 hour
Percentage of patients with concomitant medication that may affect the amount of sodium in the blood by type, dosage, duration of treatment
Measured: At the time of the consultation, anticipated average 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start3 Oct 2023
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casen Recordati S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121583
- Sponsor's protocol ID
- LAXAP-CASEN-NI 0600
- Acronym
- LAXAP
- Status last verified
- Jan 2024
- First submitted
- 31 Oct 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no IMPD object of the study
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional, Non-randomized Observational Study to Assess the Frequency of Reduced Sodium Intake in the Primary Care Setting - LAXAP
- ClinicalTrials.gov ID
- NCT06121583
- Acronym / sponsor ID
- LAXAP / LAXAP-CASEN-NI 0600
- Conditions
- Dietary Deficiency, Sodium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Casen Recordati S.L.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (over 60 years of age or older) who attend primary care units
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
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
Percentage of patients with constipation
Time frame: At the time of the consultation, anticipated average 1 hour
Percentage of patients who take laxatives
Time frame: At 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.
Time frame: At the time of the consultation, anticipated average 1 hour
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
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
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
Description of each of the study populations
Time frame: At the time of the consultation, anticipated average 1 hour
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No. there is no IMPD object of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Deficiency and Sodium, run by Casen Recordati S.L. at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.