Study on Sodium and Caffeine in Children and Adolescents

NCT ID: NCT02900261

Last Updated: 2018-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-28

Study Completion Date

2018-02-18

Brief Summary

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This study will compare different methods (24 hour urine collection, evening and morning spots, and questionnaires) to measure the consumption of sodium and cafeine in children and adolescents.

Detailed Description

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Sodium consumption among adults is high in Switzerland, as in most parts of the world. It is expected to be high in children as well, but little is still known. 24 hour urine collection is the golden standard to assess sodium consumption. However, this method is logistically difficult, especially for children. Therefore, alternatives are needed. Urinary spots have been used as a proxy to estimate sodium excretion over 24 hour in adults, but not in children. This study will assess whether urinary spots can be used to estimate sodium consumption in children in comparison to 24 hour urine collections.

Caffeine consumption has risen in children over the past years, mainly before of the increase in consumption of soda drinks. A precise way to measure caffeine consumption is by assessing the concentration of caffeine and its metabolites in 24 hour urine samples. An alternative to 24 hour urine collection is using questionnaires, however this remains difficult due to the multiples food sources of caffeine. This study will compare caffeine consumption estimated by 24 hour urine collection and by a semi-quantitative food frequency questionnaire targeting caffeine containing products.

Conditions

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Sodium Caffeine

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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No intervention

This study is observational and does not entail any intervention. Different methods to assess sodium and caffeine consumption will be compared.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Between 6 and 16 years of age

Exclusion Criteria

* A sickness that affects the consumption and excretion of sodium and caffeine (for example, diabetes, cardiovascular or gastrointestinal problems, chronic kidney disease, renal insufficiency)
* Taking medication that affects sodium excretion (for example, diuretics)
* A intravenous perfusion during the urine collection
* Insufficient knowledge of French to understand the instructions
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital du Valais

OTHER

Sponsor Role collaborator

Federal Food Safety and Veterinary Office

UNKNOWN

Sponsor Role collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Arnaud Chiolero

Epidemiologist & Senior lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arnaud Chiolero, MD PhD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Hôpital du Valais

Sion, Valais, Switzerland

Site Status

Countries

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Switzerland

References

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Paccaud Y, Rios-Leyvraz M, Bochud M, Tabin R, Genin B, Russo M, Rossier MF, Bovet P, Chiolero A, Parvex P. Spot urine samples to estimate 24-hour urinary calcium excretion in school-age children. Eur J Pediatr. 2020 Nov;179(11):1673-1681. doi: 10.1007/s00431-020-03662-z. Epub 2020 May 9.

Reference Type DERIVED
PMID: 32388721 (View on PubMed)

Rios-Leyvraz M, Bochud M, Tabin R, Genin B, Russo M, Rossier MF, Eap CB, Bovet P, Chiolero A. Monitoring caffeine intake in children with a questionnaire and urine collection: a cross-sectional study in a convenience sample in Switzerland. Eur J Nutr. 2020 Dec;59(8):3537-3543. doi: 10.1007/s00394-020-02187-3. Epub 2020 Feb 3.

Reference Type DERIVED
PMID: 32016643 (View on PubMed)

Rios-Leyvraz M, Bovet P, Tabin R, Genin B, Russo M, Rossier MF, Bochud M, Chiolero A. Urine Spot Samples Can Be Used to Estimate 24-Hour Urinary Sodium Excretion in Children. J Nutr. 2018 Dec 1;148(12):1946-1953. doi: 10.1093/jn/nxy211.

Reference Type DERIVED
PMID: 30517722 (View on PubMed)

Rios-Leyvraz M, Bovet P, Bochud M, Genin B, Russo M, Rossier MF, Tabin R, Chiolero A. Estimation of salt intake and excretion in children in one region of Switzerland: a cross-sectional study. Eur J Nutr. 2019 Oct;58(7):2921-2928. doi: 10.1007/s00394-018-1845-4. Epub 2018 Oct 19.

Reference Type DERIVED
PMID: 30341681 (View on PubMed)

Other Identifiers

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2016-01178

Identifier Type: -

Identifier Source: org_study_id

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