Study on Sodium and Caffeine in Children and Adolescents

April 18, 2018 updated by: Arnaud Chiolero, University of Lausanne Hospitals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Valais
      • Sion, Valais, Switzerland, 1951
        • Hopital du Valais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children between 6 and 16 years of age, following ambulatorily at the Hospital of Sion

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arnaud Chiolero, MD PhD, arnaud.chiolero@chuv.ch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2016

Primary Completion (Actual)

February 18, 2018

Study Completion (Actual)

February 18, 2018

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

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)?

Yes

IPD 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.

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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