NCT01268826

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

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

July 20, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2010

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

2 months

First QC Date

July 20, 2010

Last Update Submit

January 21, 2011

Conditions

Dehydration

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Amount of water intake at breakfast

    Day 1

  • Total energy and nutrient intake

    Day 1

Study Arms (1)

dosage of the urinary osmolality

dosage of the urinary osmolality

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

500 children aged 9-11

You may qualify if:

  • Healthy child aged 9 to 11 years old.

You may not qualify if:

  • Individual with illness
  • Individual with past history of gut or metabolic diseases
  • Past history of renal disease.
  • Child whom parents decline to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fabrice Bonnet, MD, PU-PH

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2010

First Posted

December 31, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations

FR(1)