Clinical trial NCT02900261: Study on Sodium and Caffeine in Children and Adolescents
Official title: Comparison of Methods to Measure the Consumption of Sodium and Caffeine in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sodium
Caffeine
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: Hôpital du Valais
name: Federal Food Safety and Veterinary Office
First posted: 2016-09-14
Enrollment: 101
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 6 and 16 years of age, following ambulatorily at the Hospital of Sion

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary sodium excretion
timeFrame: Over a 2-day period
measure: Urinary caffeine and related metabolites excretion
timeFrame: Over a 2-day period
Secondary outcomes:
measure: Sodium consumption
timeFrame: Over a 2-day period
measure: Urinary phosphate excretion
timeFrame: Over a 2-day period
measure: Urinary caffeine and metabolites excretion
timeFrame: Over a 2-day period
measure: Urinary albumine excretion
timeFrame: Over a 2-day period
measure: Urinary protein excretion
timeFrame: Over a 2-day period
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Hôpital du Valais
state: Valais
Study officials:
affiliation: arnaud.chiolero@chuv.ch
name: Arnaud Chiolero, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.