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

Dehydration Clinical Trial

— DESHYDRAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268826
• Other study ID #: 2010-A00482-37
• Secondary ID: LOC/10-04 - DESH
• Status: Completed
• Phase: N/A
• First received: July 20, 2010
• Last updated: January 21, 2011
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 11 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dehydration

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of dehydration (as defined as urinary osmolality > 800 mOsmol/l) Osmolality is measured by freezing point depression	Prevalence of dehydration (as defined as urinary osmolality > 800 mOsmol/l) Osmolality is measured by freezing point depression	Day 1	No
Secondary	Amount of water intake at breakfast	To determine whether urinary osmolality is correlated to total water intake at breakfast	Day 1	No
Secondary	Total energy and nutrient intake	To determine whether urinary osmolality is correlated to nutrient and energy intake at breakfast.	Day 1	No