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DESHYDRAT : Assessment of the Prevalence of Dehydration Among 9 to 11 Year-old Children

This study has been completed.
Sponsor:
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01268826
First received: July 20, 2010
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  Purpose

The aim of the study is to determinate the prevalence of moderate dehydration among children aged 9 to 11 who are going to school.


Condition
Dehydration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: DESHYDRAT : Assessment of the Prevalence of Dehydration Among 9 to 11 Year-old Children.

Resource links provided by NLM:

MedlinePlus related topics: Dehydration
U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Prevalence of dehydration (as defined as urinary osmolality > 800 mOsmol/l) Osmolality is measured by freezing point depression [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Prevalence of dehydration (as defined as urinary osmolality > 800 mOsmol/l) Osmolality is measured by freezing point depression


Secondary Outcome Measures:
  • Amount of water intake at breakfast [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    To determine whether urinary osmolality is correlated to total water intake at breakfast

  • Total energy and nutrient intake [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    To determine whether urinary osmolality is correlated to nutrient and energy intake at breakfast.


Biospecimen Retention:   Samples Without DNA

Urine


Estimated Enrollment: 500
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
dosage of the urinary osmolality
dosage of the urinary osmolality

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.

  Eligibility

Ages Eligible for Study:   9 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

500 children aged 9-11

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268826

Locations
France
Rennes University Hospital
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Fabrice Bonnet, MD, PU-PH Rennes University Hospital
  More Information

No publications provided

Responsible Party: Direction of Clinical Research, Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01268826     History of Changes
Other Study ID Numbers: 2010-A00482-37, LOC/10-04 - DESHYDRAT, B100522-20
Study First Received: July 20, 2010
Last Updated: January 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013