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Study on Sodium and Caffeine in Children and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02900261
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
Hôpital du Valais
Federal Food Safety and Veterinary Office
Information provided by (Responsible Party):
Arnaud Chiolero, University of Lausanne Hospitals

Study Description
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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.

Condition or disease Intervention/treatment
Sodium Caffeine Other: No intervention

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Groups and Cohorts
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Intervention Details:
  • Other: No intervention
    This study is observational and does not entail any intervention. Different methods to assess sodium and caffeine consumption will be compared.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Urine samples

Eligibility Criteria
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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
Study Population
Children between 6 and 16 years of age, following ambulatorily at the Hospital of Sion
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Switzerland
Hôpital du Valais
Sion, Valais, Switzerland, 1951
Sponsors and Collaborators
University of Lausanne Hospitals
Hôpital du Valais
Federal Food Safety and Veterinary Office
Investigators
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Principal Investigator: Arnaud Chiolero, MD PhD arnaud.chiolero@chuv.ch
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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.
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents