Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Urinary Sodium Excretion, Salt Intakes, Body Weight. Basic parameters: 7 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children and Its Effects on Body Weight and Blood Pressure
Overview
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.
Primary outcome measures
- 24-h urinary sodium excretion in Spanish schoolchildren [Time frame: Through study completion, an average of 2 years]
Secondary outcome measures (1)
- Common sodium food sources [Time frame: Through study completion, an average of 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Ecologic or community
Study locations
Spain · 1 center
- Dto. Nutrición y Ciencia de los Alimentos (NUTRYCIAL). Facultad de Farmacia. UCM — Madrid
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. PMID 26482149
Identifiers
NCT: NCT03465657 · PR6/13-18866