Study on Sodium and Caffeine in Children and Adolescents

Caffeine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900261
• Other study ID #: 2016-01178
• Status: Completed
• First received: September 9, 2016
• Last updated: April 18, 2018
• Start date: September 28, 2016
• Est. completion date: February 18, 2018

Study information

• Verified date: April 2018
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 18, 2018
• Est. primary completion date: February 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Caffeine
• Sodium

Intervention

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

Locations

Country	Name	City	State
Switzerland	Hôpital du Valais	Sion	Valais

Sponsors (3)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	Federal Food Safety and Veterinary Office, Hôpital du Valais

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary sodium excretion	Measured in 24 hour urine and estimated from 3 different urinary spots	Over a 2-day period
Primary	Urinary caffeine and related metabolites excretion	Measured in 24 hour urine and estimated by a semi-quantitative food frequency questionnaire	Over a 2-day period
Secondary	Sodium consumption	Estimated by a semi-quantitative food frequency questionnaire	Over a 2-day period
Secondary	Urinary phosphate excretion	Measured in 24 hour urine and estimated from 3 different urinary spots	Over a 2-day period
Secondary	Urinary caffeine and metabolites excretion	Measured in 24 hour urine and estimated from 3 different urinary spots	Over a 2-day period
Secondary	Urinary albumine excretion	Measured in 24 hour urine and estimated from 3 different urinary spots	Over a 2-day period
Secondary	Urinary protein excretion	Measured in 24 hour urine and estimated from 3 different urinary spots	Over a 2-day period