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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Body Weight; Urinary Sodium Excretion; Salt Intakes

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Dto. Nutrición y Ciencia de los Alimentos (NUTRYCIAL). Facultad de Farmacia. UCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: Rosa M Ortega Anta, Full Prof., Universidad Complutense de Madrid

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2013
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2050

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (ACTUAL): March 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2018
• Last Update Submitted That Met QC Criteria: March 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Blood Pressure; BMI; Child Health; Sodium intake; Urinary sodium excretion; Food Sources
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: PR6/13-18866

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No