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

• Conditions: Salt Intakes; Urinary Sodium Excretion; Body Weight

• Registration Number: NCT03465657
• Lead Sponsor: Universidad Complutense de Madrid

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

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.

Study Timeline

• Study Start: 2013-10-10
• Status Verified: 2018-03
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-13
• Last Update Submitted: 2018-03-13
• Study First Posted: 2018-03-14
• Last Update Posted: 2018-03-14
• Primary Completion: 2019-12
• Study Completion: 2050-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dto. Nutrición y Ciencia de los Alimentos (NUTRYCIAL). Facultad de Farmacia. UCM; 🇪🇸 Madrid, Spain