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

Body Weight Clinical Trial

Official title:

Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children and Its Effects on Body Weight and Blood Pressure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03465657
• Other study ID #: PR6/13-18866
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 6, 2018
• Last updated: March 13, 2018
• Start date: October 10, 2013
• Est. completion date: December 2050

Study information

• Verified date: March 2018
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 2050
• Est. primary completion date: December 2019
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Salt Intakes
• Urinary Sodium Excretion

Locations

Country	Name	City	State
Spain	Dto. Nutrición y Ciencia de los Alimentos (NUTRYCIAL). Facultad de Farmacia. UCM	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Aparicio A, Rodríguez-Rodríguez E, Cuadrado-Soto E, Navia B, López-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/s00 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Common sodium food sources	Quantify the contribution of different foods to the total sodium intake	Through study completion, an average of 2 years