Study on Sodium and Caffeine in Children and Adolescents

Completed

• Conditions: Caffeine; Sodium

• Registration Number: NCT02900261
• Lead Sponsor: University of Lausanne Hospitals

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.

Study Timeline

• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-14
• Study Start: 2016-09-28
• Primary Completion: 2018-02-18
• Study Completion: 2018-02-18
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urinary sodium excretion	Over a 2-day period	Measured in 24 hour urine and estimated from 3 different urinary spots
Urinary caffeine and related metabolites excretion	Over a 2-day period	Measured in 24 hour urine and estimated by a semi-quantitative food frequency questionnaire

Secondary Outcome Measures

Name	Time	Method
Urinary phosphate excretion	Over a 2-day period	Measured in 24 hour urine and estimated from 3 different urinary spots
Sodium consumption	Over a 2-day period	Estimated by a semi-quantitative food frequency questionnaire
Urinary caffeine and metabolites excretion	Over a 2-day period	Measured in 24 hour urine and estimated from 3 different urinary spots
Urinary albumine excretion	Over a 2-day period	Measured in 24 hour urine and estimated from 3 different urinary spots
Urinary protein excretion	Over a 2-day period	Measured in 24 hour urine and estimated from 3 different urinary spots

Trial Locations

Locations (1)

Hôpital du Valais; 🇨🇭 Sion, Valais, Switzerland