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

NCT03465657 | Enrolling By Invitation

• 1 other identifier: PR6/13-18866
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Sodium Excretion; Salt Intakes; Body Weight

Keywords

Child Health; Sodium intake; Food Sources; Blood Pressure; BMI; Urinary sodium excretion

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Common sodium food sources

  Through study completion, an average of 2 years

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age between 7 and 11 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

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

Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 26482149 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

The 24-h urine sample were collected and kept for future analysis

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rosa M Ortega Anta, Full Prof.

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 14, 2018
• Study Start: October 10, 2013
• Primary Completion: December 1, 2019
• Study Completion (Estimated): December 1, 2050
• Last Updated: March 14, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)