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

NCT ID: NCT03465657

Last Updated: 2018-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-10

Study Completion Date

2050-12-31

Brief Summary

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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

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Specific Aims

1. To stablish the average sodium intake in Spanish children, using a 24-h urine sample and validated dietary questionnaires.
2. To compare 24-hour urinary sodium measurement to the dietary survey method
3. To study the relationship between sodium intake and blood pressure levels in Spanish scholars.
4. To analyze the relationship between sodium intake and overweight/obesity in Spanish children using anthropometric and bioimpedance analysis measures.
5. To identify main food sources of sodium in the diet of Spanish schoolchildren and the use of discretionary salt.
6. Provide new data for monitoring sodium intake in Spanish schoolchildren and design campaigns to reduce their intake.
7. To provide reference data of sodium intake on a representative sample of the Spanish child population for European and international databases.

Conditions

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Urinary Sodium Excretion Salt Intakes Body Weight

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Rosa María Ortega Anta

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rosa M Ortega Anta, Full Prof.

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Locations

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Dto. Nutrición y Ciencia de los Alimentos (NUTRYCIAL). Facultad de Farmacia. UCM

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 26482149 (View on PubMed)

Other Identifiers

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PR6/13-18866

Identifier Type: -

Identifier Source: org_study_id

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