- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02900261
Study on Sodium and Caffeine in Children and Adolescents
Comparison of Methods to Measure the Consumption of Sodium and Caffeine in Children
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Valais
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Sion, Valais, Switzerland, 1951
- Hopital du Valais
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary sodium excretion
Time Frame: Over a 2-day period
|
Measured in 24 hour urine and estimated from 3 different urinary spots
|
Over a 2-day period
|
Urinary caffeine and related metabolites excretion
Time Frame: Over a 2-day period
|
Measured in 24 hour urine and estimated by a semi-quantitative food frequency questionnaire
|
Over a 2-day period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sodium consumption
Time Frame: Over a 2-day period
|
Estimated by a semi-quantitative food frequency questionnaire
|
Over a 2-day period
|
Urinary phosphate excretion
Time Frame: Over a 2-day period
|
Measured in 24 hour urine and estimated from 3 different urinary spots
|
Over a 2-day period
|
Urinary caffeine and metabolites excretion
Time Frame: Over a 2-day period
|
Measured in 24 hour urine and estimated from 3 different urinary spots
|
Over a 2-day period
|
Urinary albumine excretion
Time Frame: Over a 2-day period
|
Measured in 24 hour urine and estimated from 3 different urinary spots
|
Over a 2-day period
|
Urinary protein excretion
Time Frame: Over a 2-day period
|
Measured in 24 hour urine and estimated from 3 different urinary spots
|
Over a 2-day period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arnaud Chiolero, MD PhD, arnaud.chiolero@chuv.ch
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2016-01178
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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