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

July 28, 2018 updated by: Naiman Khan, University of Illinois at Urbana-Champaign

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Department of Kinesiology and Community Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Parental/guardian consent
  2. 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:

  1. Participants younger than 9 years and older than 10 years at the time of testing age.
  2. Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).
  3. 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).
  4. 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
  5. IQ below 85
  6. Use of medications that alter urinary excretion and water metabolism
  7. Use of internal electronic device, such as a pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIGH
Increase water intake to 2.5 liters per day for 4 days
Behavioral: Water Intake
Experimental: LOW
Decrease water intake to 0.5 liter per day for 4 days
Behavioral: Water Intake

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Collaborators

Danone Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 28, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14701 (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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