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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

From the registry’s dates

  • Primary completion was expected by Dec 2019, 6 years 11 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
400
Ages
7 Years to 11 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Body Weight with a site in Spain — 7 open to participants now, 10 under way, 3 of them phase 3. Body Weight · Spain.

Started
2013
the only one that year
Observational
5 of 22
2 open now
Registered
7th of 22
by date

Among the 22 studies in Body Weight with a site in Spain, this one is the only one that started in 2013, is one of 5 observational ones, and was the 7th registered.

Body Weight

657 studies on the registry are indexed under Body Weight; 76 are open to participants now.

Browse Body Weight studies →

Open to participants now

7 of the 22 studies in Body Weight with a site in Spain are open now. Recruiting first, the newest first:

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All 7 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 51 Body Weight studies recruiting now, 20 (39%) set no upper age limit and 29 (57%) stop at 75 or younger; 6 take children under 18; 16 take healthy volunteers.

This study: 7 Years to 11 Years · all sexes.

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02

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.
03

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
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

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

07

Study locations

1 site
  • Dto. Nutrición y Ciencia de los Alimentos (NUTRYCIAL). Facultad de Farmacia. UCM
    Madrid, 28040, Spain
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2013 (actual). Primary completion is estimated for Dec 2019, 74 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2018
First posted
Mar 14, 2018
StartActual
Oct 10, 2013
Primary completionEst.
Dec 2019
CompletionEst.
Dec 2050
Last update
Mar 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03465657
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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No contact was published for this record. The registry link below has the sponsor’s details.

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