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SodiumNCT02900261

Study on Sodium and Caffeine in Children and Adolescents

An observational study of Sodium and Caffeine, run by University of Lausanne Hospitals at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Sodium, Caffeine
How many people
101 participants
Where
1 siteSwitzerland
Study dates
28 Sep 2016to 18 Feb 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children between 6 and 16 years of age, following ambulatorily at the Hospital of Sion

Who may be able to join

  • Between 6 and 16 years of age

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Hôpital du Valais

    Sion, Valais, 1951

Other trials in Switzerland

About this study

Official title: Comparison of Methods to Measure the Consumption of Sodium and Caffeine in Children

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.

Read the detailed description

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
Sodium, Caffeine
Being tested
No intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urinary sodium excretion

    Measured in 24 hour urine and estimated from 3 different urinary spots

    Measured: Over a 2-day period

  2. Urinary caffeine and related metabolites excretion

    Measured in 24 hour urine and estimated by a semi-quantitative food frequency questionnaire

    Measured: Over a 2-day period

Secondary outcomes (5)

  1. Sodium consumption

    Estimated by a semi-quantitative food frequency questionnaire

    Measured: Over a 2-day period

  2. Urinary phosphate excretion

    Measured in 24 hour urine and estimated from 3 different urinary spots

    Measured: Over a 2-day period

  3. Urinary caffeine and metabolites excretion

    Measured in 24 hour urine and estimated from 3 different urinary spots

    Measured: Over a 2-day period

  4. Urinary albumine excretion

    Measured in 24 hour urine and estimated from 3 different urinary spots

    Measured: Over a 2-day period

  5. Urinary protein excretion

    Measured in 24 hour urine and estimated from 3 different urinary spots

    Measured: Over a 2-day period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2016 (estimated)
  2. Study start28 Sep 2016
  3. Primary completion18 Feb 2018
  4. Study completion18 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02900261
Sponsor's protocol ID
2016-01178
Other IDs
2016
Status last verified
Apr 2018
First submitted
9 Sep 2016
Last updated
20 Apr 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: The results of this study will be published in an article. The full dataset will be made available in the DATA@IUMSP repository, http://data.iumsp.ch.

Publications

  • 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.

    PubMed 32388721

  • 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.

    PubMed 32016643

  • 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.

    PubMed 30517722

  • 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.

    PubMed 30341681

Questions about this trial

What is this clinical trial studying?

An observational study of Sodium and Caffeine, run by University of Lausanne Hospitals at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary sodium excretion (time frame: Over a 2-day period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02900261, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.

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