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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Metabolic Diseases
Pathologic Processes
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on November 24, 2014