Urinary Sodium ExcretionNCT03465657
Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children
An observational study of Urinary Sodium Excretion and Salt Intakes, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Previous evidence shows that sodium intake in Spanish adult population is over the recommended limits and this high sodium intake is related with difficulties in body weight control and blood pressure control. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Urinary Sodium Excretion, Salt Intakes, Body Weight
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2013to Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 to 11 years
- All sexes
- Child
Study population: Representative population of Spanish Children between 7-11 years old from schools of different regional communities.
Who may be able to join
- Age between 7 and 11 years old
Who cannot join
- Those who have any clinical problem, which may modify the results of the analysis: metabolic or chronic diseases (liver, kidney, diabetes, hypothesis or hyperkalemia), pharmacological treatment during the 3 months prior to the study with corticosteroids, insulin, diuretics or other drugs that may modify blood pressure figures, surgery or serious infectious diseases in the previous 6 months.
- Those who were not in the school when the measures were taken.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Dto. Nutrición y Ciencia de los Alimentos (NUTRYCIAL). Facultad de Farmacia. UCM
Madrid, 28040
About this study
Official title: Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children and Its Effects on Body Weight and Blood Pressure
Previous evidence shows that sodium intake in Spanish adult population is over the recommended limits and this high sodium intake is related with difficulties in body weight control and blood pressure control.
The aim of this study is to stablish a direct relationship between salt intake and the health parameters previously mentioned in a representative sample of Spanish schoolchildren between 7-11 years old. The investigators are applying a 3-day dietary records to collect dietary data, and collecting 24-h urine samples in order to analyse biochemical indicators of sodium intake and other nutrients. Anthropometric data are also being recorded and body composition is also analysed using bioimpedance technique.
Read the detailed description
Specific Aims
- To stablish the average sodium intake in Spanish children, using a 24-h urine sample and validated dietary questionnaires.
- To compare 24-hour urinary sodium measurement to the dietary survey method
- To study the relationship between sodium intake and blood pressure levels in Spanish scholars.
- To analyze the relationship between sodium intake and overweight/obesity in Spanish children using anthropometric and bioimpedance analysis measures.
- To identify main food sources of sodium in the diet of Spanish schoolchildren and the use of discretionary salt.
- Provide new data for monitoring sodium intake in Spanish schoolchildren and design campaigns to reduce their intake.
- To provide reference data of sodium intake on a representative sample of the Spanish child population for European and international databases.
- Conditions
- Urinary Sodium Excretion, Salt Intakes, Body Weight
- Keywords
- Child Health, Sodium intake, Food Sources, Blood Pressure, BMI, Urinary sodium excretion
- Medical subject headings
- Body Weight
What is being measured
The primary outcome is the main question the study is designed to answer.
24-h urinary sodium excretion in Spanish schoolchildren
Estimation of salt intake by 24 h urinary sodium excretion
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
Common sodium food sources
Quantify the contribution of different foods to the total sodium intake
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start10 Oct 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Sodium ExcretionStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa María Ortega Anta, Universidad Complutense de Madrid
- Investigators
- Rosa M Ortega Anta, Full Prof., Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465657
- Sponsor's protocol ID
- PR6/13-18866
- Status last verified
- Mar 2018
- First submitted
- 6 Mar 2018
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aparicio A, Rodriguez-Rodriguez E, Cuadrado-Soto E, Navia B, Lopez-Sobaler AM, Ortega RM. Estimation of salt intake assessed by urinary excretion of sodium over 24 h in Spanish subjects aged 7-11 years. Eur J Nutr. 2017 Feb;56(1):171-178. doi: 10.1007/s00394-015-1067-y. Epub 2015 Oct 19.
PubMed 26482149
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children and Its Effects on Body Weight and Blood Pressure
- ClinicalTrials.gov ID
- NCT03465657
- Acronym / sponsor ID
- PR6/13-18866
- Conditions
- Urinary Sodium Excretion, Salt Intakes, Body Weight
- Keywords
- Child Health, Sodium intake, Food Sources, Blood Pressure, BMI, Urinary sodium excretion
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 10 Oct 2013 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 14 Mar 2018 (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.
Previous evidence shows that sodium intake in Spanish adult population is over the recommended limits and this high sodium intake is related with difficulties in body weight control and blood pressure control.
The aim of this study is to stablish a direct relationship between salt intake and the health parameters previously mentioned in a representative sample of Spanish schoolchildren between 7-11 years old. The investigators are applying a 3-day dietary records to collect dietary data, and collecting 24-h urine samples in order to analyse biochemical indicators of sodium intake and other nutrients. Anthropometric data are also being recorded and body composition is also analysed using bioimpedance technique.
Detailed description
Specific Aims
- To stablish the average sodium intake in Spanish children, using a 24-h urine sample and validated dietary questionnaires.
- To compare 24-hour urinary sodium measurement to the dietary survey method
- To study the relationship between sodium intake and blood pressure levels in Spanish scholars.
- To analyze the relationship between sodium intake and overweight/obesity in Spanish children using anthropometric and bioimpedance analysis measures.
- To identify main food sources of sodium in the diet of Spanish schoolchildren and the use of discretionary salt.
- Provide new data for monitoring sodium intake in Spanish schoolchildren and design campaigns to reduce their intake.
- To provide reference data of sodium intake on a representative sample of the Spanish child population for European and international databases.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Age groups
- Child
- Study population
- Representative population of Spanish Children between 7-11 years old from schools of different regional communities.
Key inclusion criteria (1 listed)
- Age between 7 and 11 years old
Key exclusion criteria (2 listed)
- Those who have any clinical problem, which may modify the results of the analysis: metabolic or chronic diseases (liver, kidney, diabetes, hypothesis or hyperkalemia), pharmacological treatment during the 3 months prior to the study with corticosteroids, insulin, diuretics or other drugs that may modify blood pressure figures, surgery or serious infectious diseases in the previous 6 months.
- Those who were not in the school when the measures were taken.
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
24-h urinary sodium excretion in Spanish schoolchildren
Time frame: Through study completion, an average of 2 years
Estimation of salt intake by 24 h urinary sodium excretion
1 secondary outcome
Common sodium food sources
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Results publication: PubMed 26482149Aparicio A, Rodriguez-Rodriguez E, Cuadrado-Soto E, Navia B, Lopez-Sobaler AM, Ortega RM. Estimation of salt intake assessed by urinary excretion of sodium over 24 h in Spanish subjects aged 7-11 years. Eur J Nutr. 2017 Feb;56(1):171-178. doi: 10.1007/s00394-015-1067-y. Epub 2015 Oct 19.
- Individual participant dataSharing planned: No
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.
Rosa M Ortega Anta, Full Prof. principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Sodium Excretion and Salt Intakes, run by Universidad Complutense de Madrid at 1 site 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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
24-h urinary sodium excretion in Spanish schoolchildren (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465657, which also lists 1 linked publication.
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 14 Mar 2018.