Low Fluid Intake, ChronicWITiKidsNCT02816450
Water Intervention for Thinking in Kids (WITiKids ) Study
A study testing Water Intake in people with Low Fluid Intake, Chronic, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The aim of this study is to determine the influence of changes in water intake on changes in cognitive function among preadolescent children. Further, the proposed work will determine the relationship between urinary markers of hydration process and cognitive function. Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Fluid Intake, Chronic
- What is being tested?
- Water Intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2018
- Phase
- Interventional
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parental/guardian consent
- Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
Who cannot join
- Participants younger than 9 years and older than 10 years at the time of testing age.
- Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
- Use of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for ADD/ADHD (use of any anti-psychotic, anti-depressant, anti-anxiety, and ADD/ADHD medications).
- Participants must have not yet reached, or be in the earliest stages, of puberty, as measured by a modified test of the Tanner Staging System
- IQ below 85
- Use of medications that alter urinary excretion and water metabolism
- Use of internal electronic device, such as a pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology and Community Health
Urbana, Illinois, 61801
About this study
Official title: The Effects of Hydration on Brain, Cognition, Memory & Achievement in Childhood
The aim of this study is to determine the influence of changes in water intake on changes in cognitive function among preadolescent children. Further, the proposed work will determine the relationship between urinary markers of hydration process and cognitive function. We hypothesize that an increase in water intake will result in greater cognitive performance. In addition, improvements in hydration demonstrated by lower urine concentration will be correlated with greater cognitive performance.
- Conditions
- Low Fluid Intake, Chronic
- Being tested
- Water Intake
- Keywords
- Water, Children, Cognition, Hydration
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water IntakeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| HIGH | Experimental | Increase water intake to 2.5 liters per day for 4 days Receives: Behavioral: Water Intake |
| LOW | Experimental | Decrease water intake to 0.5 liter per day for 4 days Receives: Behavioral: Water Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flanker Task Accuracy
Measured: 2 Hours on the morning of Day 5
Secondary outcomes (1)
Urine Osmolality
Measured: 24 hours during final day of fluid intake modulation (Day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2014
- Primary completionOct 2015
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Fluid Intake, ChronicStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Principal investigator, Naiman Khan, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816450
- Sponsor's protocol ID
- 14701
- Acronym
- WITiKids
- Status last verified
- Jul 2018
- First submitted
- 17 Jun 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
Publications
Khan NA, Westfall DR, Jones AR, Sinn MA, Bottin JH, Perrier ET, Hillman CH. A 4-d Water Intake Intervention Increases Hydration and Cognitive Flexibility among Preadolescent Children. J Nutr. 2019 Dec 1;149(12):2255-2264. doi: 10.1093/jn/nxz206.
PubMed 31504690
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hydration on Brain, Cognition, Memory & Achievement in Childhood
- ClinicalTrials.gov ID
- NCT02816450
- Acronym / sponsor ID
- WITiKids / 14701
- Conditions
- Low Fluid Intake, Chronic
- Keywords
- Water, Children, Cognition, Hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- Jun 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 28 Jun 2016 (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 this study is to determine the influence of changes in water intake on changes in cognitive function among preadolescent children. Further, the proposed work will determine the relationship between urinary markers of hydration process and cognitive function. We hypothesize that an increase in water intake will result in greater cognitive performance. In addition, improvements in hydration demonstrated by lower urine concentration will be correlated with greater cognitive performance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIGH | Experimental | Behavioral: Water IntakeIncrease water intake to 2.5 liters per day for 4 days |
| LOW | Experimental | Behavioral: Water IntakeDecrease water intake to 0.5 liter per day for 4 days |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parental/guardian consent
- Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
Key exclusion criteria (7 listed)
- Participants younger than 9 years and older than 10 years at the time of testing age.
- Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
- Use of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for ADD/ADHD (use of any anti-psychotic, anti-depressant, anti-anxiety, and ADD/ADHD medications).
- Participants must have not yet reached, or be in the earliest stages, of puberty, as measured by a modified test of the Tanner Staging System
- IQ below 85
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water Intake | Behavioural | HIGH, LOW |
Primary outcome
Flanker Task Accuracy
Time frame: 2 Hours on the morning of Day 5
1 secondary outcome
Urine Osmolality
Time frame: 24 hours during final day of fluid intake modulation (Day 4)
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 31 Jul 2018.
- Derived from this study: PubMed 31504690Khan NA, Westfall DR, Jones AR, Sinn MA, Bottin JH, Perrier ET, Hillman CH. A 4-d Water Intake Intervention Increases Hydration and Cognitive Flexibility among Preadolescent Children. J Nutr. 2019 Dec 1;149(12):2255-2264. doi: 10.1093/jn/nxz206.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Intake in people with Low Fluid Intake, Chronic, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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 2 inclusion and 7 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 31 Jul 2018. 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 United States. 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?
Flanker Task Accuracy (time frame: 2 Hours on the morning of Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816450, which also lists 1 linked publication.
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 31 Jul 2018.