NCT02900261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

September 28, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2018

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

1.4 years

First QC Date

September 9, 2016

Last Update Submit

April 18, 2018

Conditions

SodiumCaffeine

Outcome Measures

Primary Outcomes (2)

  • Urinary sodium excretion

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

    Over a 2-day period

  • 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 Outcomes (5)

  • Sodium consumption

    Over a 2-day period

  • Urinary phosphate excretion

    Over a 2-day period

  • Urinary caffeine and metabolites excretion

    Over a 2-day period

  • Urinary albumine excretion

    Over a 2-day period

  • Urinary protein excretion

    Over a 2-day period

Interventions

No interventionOTHER

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

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Between 6 and 16 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital du Valais

Sion, Valais, 1951, Switzerland

Location

Related Publications (4)

  • Paccaud Y, Rios-Leyvraz M, Bochud M, Tabin R, Genin B, Russo M, Rossier MF, Bovet P, Chiolero A, Parvex P. Spot urine samples to estimate 24-hour urinary calcium excretion in school-age children. Eur J Pediatr. 2020 Nov;179(11):1673-1681. doi: 10.1007/s00431-020-03662-z. Epub 2020 May 9.

    PMID: 32388721DERIVED

  • Rios-Leyvraz M, Bochud M, Tabin R, Genin B, Russo M, Rossier MF, Eap CB, Bovet P, Chiolero A. Monitoring caffeine intake in children with a questionnaire and urine collection: a cross-sectional study in a convenience sample in Switzerland. Eur J Nutr. 2020 Dec;59(8):3537-3543. doi: 10.1007/s00394-020-02187-3. Epub 2020 Feb 3.

    PMID: 32016643DERIVED

  • Rios-Leyvraz M, Bovet P, Tabin R, Genin B, Russo M, Rossier MF, Bochud M, Chiolero A. Urine Spot Samples Can Be Used to Estimate 24-Hour Urinary Sodium Excretion in Children. J Nutr. 2018 Dec 1;148(12):1946-1953. doi: 10.1093/jn/nxy211.

    PMID: 30517722DERIVED

  • Rios-Leyvraz M, Bovet P, Bochud M, Genin B, Russo M, Rossier MF, Tabin R, Chiolero A. Estimation of salt intake and excretion in children in one region of Switzerland: a cross-sectional study. Eur J Nutr. 2019 Oct;58(7):2921-2928. doi: 10.1007/s00394-018-1845-4. Epub 2018 Oct 19.

    PMID: 30341681DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

Study Officials

  • Arnaud Chiolero, MD PhD

    arnaud.chiolero@chuv.ch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Epidemiologist & Senior lecturer

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 14, 2016

Study Start

September 28, 2016

Primary Completion

February 18, 2018

Study Completion

February 18, 2018

Last Updated

April 20, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

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.

Locations

CH(1)