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Enrolling by invitationNCT03465657Updated Mar 14, 2018

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

An observational study in Urinary Sodium Excretion, Salt Intakes and Body Weight, sponsored by Universidad Complutense de Madrid. Enrolling by invitation at 1 site in Spain. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2018-03-14.

Sponsored by Universidad Complutense de Madrid · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
400
Ages
7 Years to 11 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Urinary Sodium Excretion
  • Salt Intakes
  • Body Weight

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Keywords

  • Child Health
  • Sodium intake
  • Food Sources
  • Blood Pressure
  • BMI
  • Urinary sodium excretion
03

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Age between 7 and 11 years old

Exclusion criteria

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.
04

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
05

What researchers measure

Primary outcomes

  1. 24-h urinary sodium excretion in Spanish schoolchildren

    Estimation of salt intake by 24 h urinary sodium excretion

    Time frame: Through study completion, an average of 2 years

Secondary outcomes

  1. Common sodium food sources

    Quantify the contribution of different foods to the total sodium intake

    Time frame: Through study completion, an average of 2 years

06

Study locations

1 site
  • Dto. Nutrición y Ciencia de los Alimentos (NUTRYCIAL). Facultad de Farmacia. UCM
    Madrid, 28040, Spain
07

References and documents

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. PubMed 26482149 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03465657
Lead sponsor
Universidad Complutense de Madrid
Responsible party
Rosa María Ortega Anta (Full Professor, Universidad Complutense de Madrid) — Principal investigator
First posted
Mar 14, 2018
Start date
Oct 10, 2013
Primary completion
Dec 2019 (estimated)
Completion
Dec 2050 (estimated)
Last update
Mar 14, 2018

Study contacts

Rosa M Ortega Anta, Full Prof.
principal investigator · Universidad Complutense de Madrid

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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