DehydrationDESHYDRATNCT01268826
DESHYDRAT : Assessment of the Prevalence of Dehydration Among 9 to 11 Year-old Children
An observational study of Dehydration, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 500 children aged 9-11
Who may be able to join
- Healthy child aged 9 to 11 years old.
Who cannot join
- Individual with illness
- Individual with past history of gut or metabolic diseases
- Past history of renal disease.
- Child whom parents decline to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dehydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dosage of the urinary osmolality | dosage of the urinary osmolality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (2)
Amount of water intake at breakfast
To determine whether urinary osmolality is correlated to total water intake at breakfast
Measured: Day 1
Total energy and nutrient intake
To determine whether urinary osmolality is correlated to nutrient and energy intake at breakfast.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Fabrice Bonnet, MD, PU-PH, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268826
- Sponsor's protocol ID
- 2010-A00482-37
- Other IDs
- LOC/10-04 - DESHYDRAT, B100522-20
- Acronym
- DESHYDRAT
- Status last verified
- Jan 2011
- First submitted
- 20 Jul 2010
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DESHYDRAT : Assessment of the Prevalence of Dehydration Among 9 to 11 Year-old Children.
- ClinicalTrials.gov ID
- NCT01268826
- Acronym / sponsor ID
- DESHYDRAT / 2010-A00482-37
- Conditions
- Dehydration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to determinate the prevalence of moderate dehydration among children aged 9 to 11 who are going to school.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dosage of the urinary osmolality | – | –dosage of the urinary osmolality |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 500 children aged 9-11
Key inclusion criteria (1 listed)
- Healthy child aged 9 to 11 years old.
Key exclusion criteria (4 listed)
- Individual with illness
- Individual with past history of gut or metabolic diseases
- Past history of renal disease.
- Child whom parents decline to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of dehydration (as defined as urinary osmolality > 800 mOsmol/l) Osmolality is measured by freezing point depression
Time frame: Day 1
Prevalence of dehydration (as defined as urinary osmolality > 800 mOsmol/l) Osmolality is measured by freezing point depression
2 secondary outcomes
Amount of water intake at breakfast
Time frame: Day 1
Total energy and nutrient intake
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice Bonnet, MD, PU-PH principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of dehydration (as defined as urinary osmolality > 800 mOsmol/l) Osmolality is measured by freezing point depression (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2011.