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

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.

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Key information

Conditions

Urinary Sodium Excretion Body Weight Pathological Conditions, Signs and Symptoms Salt Intakes Signs and Symptoms

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Madrid, 28040, Spain

About this study

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.

Who can participate

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

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.

Treatment and study plan

Primary outcomes

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

Secondary outcomes

Common sodium food sources

Time frame: Through study completion, an average of 2 years

Quantify the contribution of different foods to the total sodium intake

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children and Its Effects on Body Weight and Blood Pressure

Important dates

Study start: 2013
Primary completion: 2019
Study completion: 2050
First posted: Mar 14, 2018
Registry last updated: Mar 14, 2018

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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Completed