- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01268826
DESHYDRAT : Assessment of the Prevalence of Dehydration Among 9 to 11 Year-old Children (DESHYDRAT)
January 21, 2011 updated by: Rennes University Hospital
DESHYDRAT : Assessment of the Prevalence of Dehydration Among 9 to 11 Year-old Children.
The aim of the study is to determinate the prevalence of moderate dehydration among children aged 9 to 11 who are going to school.
Study Overview
Status
Completed
Conditions
Detailed Description
Many children have a limited caloric intake at the breakfast with a limited amount of water intake.
There is no data about the prevalence of dehydration in children who are regularly going to school in France.
Study Type
Observational
Enrollment (Anticipated)
500
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
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Rennes, France, 35033
- Rennes University Hospital
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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
9 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
500 children aged 9-11
Description
Inclusion Criteria:
- Healthy child aged 9 to 11 years old.
Exclusion Criteria:
- Individual with illness
- Individual with past history of gut or metabolic diseases
- Past history of renal disease.
- Child whom parents decline to participate
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: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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dosage of the urinary osmolality
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence of dehydration (as defined as urinary osmolality > 800 mOsmol/l) Osmolality is measured by freezing point depression
Time Frame: Day 1
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Prevalence of dehydration (as defined as urinary osmolality > 800 mOsmol/l) Osmolality is measured by freezing point depression
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of water intake at breakfast
Time Frame: Day 1
|
To determine whether urinary osmolality is correlated to total water intake at breakfast
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Day 1
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Total energy and nutrient intake
Time Frame: Day 1
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To determine whether urinary osmolality is correlated to nutrient and energy intake at breakfast.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fabrice Bonnet, MD, PU-PH, Rennes University Hospital
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
October 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
July 20, 2010
First Submitted That Met QC Criteria
December 30, 2010
First Posted (Estimate)
December 31, 2010
Study Record Updates
Last Update Posted (Estimate)
January 24, 2011
Last Update Submitted That Met QC Criteria
January 21, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-A00482-37
- LOC/10-04 - DESHYDRAT (Other Identifier: Rennes University Hospital)
- B100522-20 (Other Identifier: AFSSAPS)
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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