Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-28 @ 1:02 PM
Study NCT ID:
NCT02816450
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2016-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Water Intervention for Thinking in Kids (WITiKids ) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004326', 'term': 'Drinking'}], 'ancestors': [{'id': 'D004435', 'term': 'Eating'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-28', 'studyFirstSubmitDate': '2016-06-17', 'studyFirstSubmitQcDate': '2016-06-24', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flanker Task Accuracy', 'timeFrame': '2 Hours on the morning of Day 5'}], 'secondaryOutcomes': [{'measure': 'Urine Osmolality', 'timeFrame': '24 hours during final day of fluid intake modulation (Day 4)'}]}, 'conditionsModule': {'keywords': ['Water', 'Children', 'Cognition', 'Hydration'], 'conditions': ['Low Fluid Intake, Chronic']}, 'referencesModule': {'references': [{'pmid': '31504690', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Parental/guardian consent\n2. Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).\n\nExclusion Criteria:\n\n1. Participants younger than 9 years and older than 10 years at the time of testing age.\n2. Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking aid).\n3. 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).\n4. 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\n5. IQ below 85\n6. Use of medications that alter urinary excretion and water metabolism\n7. Use of internal electronic device, such as a pacemaker'}, 'identificationModule': {'nctId': 'NCT02816450', 'acronym': 'WITiKids', 'briefTitle': 'Water Intervention for Thinking in Kids (WITiKids ) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'The Effects of Hydration on Brain, Cognition, Memory & Achievement in Childhood', 'orgStudyIdInfo': {'id': '14701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIGH', 'description': 'Increase water intake to 2.5 liters per day for 4 days', 'interventionNames': ['Behavioral: Water Intake']}, {'type': 'EXPERIMENTAL', 'label': 'LOW', 'description': 'Decrease water intake to 0.5 liter per day for 4 days', 'interventionNames': ['Behavioral: Water Intake']}], 'interventions': [{'name': 'Water Intake', 'type': 'BEHAVIORAL', 'armGroupLabels': ['HIGH', 'LOW']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Department of Kinesiology and Community Health', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danone Global Research & Innovation Center', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Naiman Khan', 'investigatorAffiliation': 'University of Illinois at Urbana-Champaign'}}}}