Sodium Sources and Sodium Intake in a Representative Samp... | NCT03465657

Studies
Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children

NCT03465657

Sponsor

Universidad Complutense de Madrid

Status

Enrolling by invitation

Last Update Posted

Mar 14, 2018Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Urinary Sodium Excretion
Salt Intakes
Body Weight

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2013Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2050Estimated

First Submitted Date

Mar 6, 2018

First Submission Date that Met QC Criteria

Mar 13, 2018

First Posted Date

Mar 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2018

Last Update Posted Date

Mar 14, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rosa María Ortega Anta, Full Professor, Universidad Complutense de MadridPrincipal Investigator

Lead Sponsor

Universidad Complutense de MadridOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
24-h urinary sodium excretion in Spanish schoolchildren	Estimation of salt intake by 24 h urinary sodium excretion	Through study completion, an average of 2 years

Secondary Outcomes

Measure	Description	Time Frame
Common sodium food sources	Quantify the contribution of different foods to the total sodium intake	Through study completion, an average of 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 7 and 11 years old

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Representative population of Spanish Children between 7-11 years old from schools of different regional communities.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rosa M Ortega Anta, Full Prof.	Universidad Complutense de Madrid	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dto. Nutrición y Ciencia de los Alimentos (NUTRYCIAL). Facultad de Farmacia. UCM		Madrid		28040	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26482149	Result	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.

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms