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Completed

NCT Number: NCT02900261

Study on Sodium and Caffeine in Children and Adolescents

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.

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Key information

Conditions

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital du Valais

Sion, Valais, 1951, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Urinary sodium excretion

    Time frame: Over a 2-day period

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

  2. 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

Secondary outcomes

  1. Sodium consumption

    Time frame: Over a 2-day period

    Estimated by a semi-quantitative food frequency questionnaire

  2. Urinary phosphate excretion

    Time frame: Over a 2-day period

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

  3. Urinary caffeine and metabolites excretion

    Time frame: Over a 2-day period

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

  4. Urinary albumine excretion

    Time frame: Over a 2-day period

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

  5. Urinary protein excretion

    Time frame: Over a 2-day period

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

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Collaborators

  • Federal Food Safety and Veterinary Office
  • Hôpital du Valais

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 14, 2016
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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