Water Intervention for Thinking in Kids (WITiKids ) Study | NCT02816450

Studies
Water Intervention for Thinking in Kids (WITiKids ) Study

NCT02816450

Sponsor

University of Illinois at Urbana-Champaign

Status

Completed

Last Update Posted

Jul 31, 2018Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Low Fluid Intake, Chronic

Interventions

Water Intake

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Oct 2015Actual

Completion Date

Jun 2018Actual

First Submitted Date

Jun 17, 2016

First Submission Date that Met QC Criteria

Jun 24, 2016

First Posted Date

Jun 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2018

Last Update Posted Date

Jul 31, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Naiman Khan, Assistant Professor, University of Illinois at Urbana-ChampaignPrincipal Investigator

Lead Sponsor

University of Illinois at Urbana-ChampaignOTHER

Collaborators

Name	Class
Danone Global Research & Innovation Center	INDUSTRY

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIGH	Experimental	Increase water intake to 2.5 liters per day for 4 days	Behavioral: Water Intake
LOW	Experimental	Decrease water intake to 0.5 liter per day for 4 days	Behavioral: Water Intake

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Water Intake	Behavioral		HIGH LOW

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Flanker Task Accuracy		2 Hours on the morning of Day 5

Secondary Outcomes

Measure	Description	Time Frame
Urine Osmolality		24 hours during final day of fluid intake modulation (Day 4)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Kinesiology and Community Health		Urbana	Illinois	61801	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31504690	Derived	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.

ID	Term
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans
D001988	Bronchiolitis
D001991	Bronchitis

ID	Term
D004435	Eating
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena