Clinical trial NCT03465657: Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children
Official title: Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children and Its Effects on Body Weight and Blood Pressure
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Urinary Sodium Excretion
Salt Intakes
Body Weight
Keywords: Child Health
Sodium intake
Food Sources
Blood Pressure
BMI
Urinary sodium excretion
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 400
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Representative population of Spanish Children between 7-11 years old from schools of different regional communities.

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.

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.

Primary outcomes:
measure: 24-h urinary sodium excretion in Spanish schoolchildren
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Common sodium food sources
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Dto. Nutrición y Ciencia de los Alimentos (NUTRYCIAL). Facultad de Farmacia. UCM
Study officials:
affiliation: Universidad Complutense de Madrid
name: Rosa M Ortega Anta, Full Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.