Study on Sodium and Caffeine in Children and Adolescents
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ClinicalTrials.gov Identifier: NCT02900261 |
Recruitment Status :
Completed
First Posted : September 14, 2016
Last Update Posted : April 20, 2018
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Condition or disease | Intervention/treatment |
---|---|
Sodium Caffeine | Other: No intervention |
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 : | Observational |
Actual Enrollment : | 101 participants |
Observational Model: | Other |
Time Perspective: | Cross-Sectional |
Official Title: | Comparison of Methods to Measure the Consumption of Sodium and Caffeine in Children |
Actual Study Start Date : | September 28, 2016 |
Actual Primary Completion Date : | February 18, 2018 |
Actual Study Completion Date : | February 18, 2018 |
- Other: No intervention
This study is observational and does not entail any intervention. Different methods to assess sodium and caffeine consumption will be compared.
- Urinary sodium excretion [ Time Frame: Over a 2-day period ]Measured in 24 hour urine and estimated from 3 different urinary spots
- 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
- Sodium consumption [ Time Frame: Over a 2-day period ]Estimated by a semi-quantitative food frequency questionnaire
- Urinary phosphate excretion [ Time Frame: Over a 2-day period ]Measured in 24 hour urine and estimated from 3 different urinary spots
- Urinary caffeine and metabolites excretion [ Time Frame: Over a 2-day period ]Measured in 24 hour urine and estimated from 3 different urinary spots
- Urinary albumine excretion [ Time Frame: Over a 2-day period ]Measured in 24 hour urine and estimated from 3 different urinary spots
- Urinary protein excretion [ Time Frame: Over a 2-day period ]Measured in 24 hour urine and estimated from 3 different urinary spots
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 6 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900261
Switzerland | |
Hôpital du Valais | |
Sion, Valais, Switzerland, 1951 |
Principal Investigator: | Arnaud Chiolero, MD PhD | arnaud.chiolero@chuv.ch |
Responsible Party: | Arnaud Chiolero, Epidemiologist & Senior lecturer, University of Lausanne Hospitals |
ClinicalTrials.gov Identifier: | NCT02900261 |
Other Study ID Numbers: |
2016-01178 |
First Posted: | September 14, 2016 Key Record Dates |
Last Update Posted: | April 20, 2018 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |