Reference Values and Determinants of Hydration in Childre... | NCT02937038

Studies
Reference Values and Determinants of Hydration in Children 3-13 y

NCT02937038

Sponsor

Arizona State University

Status

Terminated

Last Update Posted

Jul 23, 2021Actual

Enrollment

1,454Actual

Phase

Not provided

Conditions

Dehydration

Interventions

Not provided

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 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID-19 difficulties recruiting

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Mar 31, 2020Actual

Completion Date

Jun 25, 2021Actual

First Submitted Date

Oct 12, 2016

First Submission Date that Met QC Criteria

Oct 17, 2016

First Posted Date

Oct 18, 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 19, 2021

Last Update Posted Date

Jul 23, 2021Actual

Name	Class
Danone Global Research & Innovation Center	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Purpose:

Develop reference values for hydration biomarkers for children of 3 to 13 years old
Explore the association between children's and parents' hydration markers and fluid intake habits in children aged 3-13 y
Evaluate the equivalence of spot urine osmolality to 24h urine osmolality in children aged 3-13 y
Evaluate the differences in hydration markers between school and non-school days in children aged 3-13 y
Examine the role of different foods and fluids on hydration in children (3-13 y) and parents

Detailed Description

Recent studies in children have indicated that greater water intake and/or lower urine concentration are associated with better overall nutrition, increased physical activity, improved mood state, and enhanced cognition; which is specifically related to superior attention and memory when compared to sub-optimally hydrated children. Separately, ancillary water is being investigated as a potential treatment possibility for pediatric obesity. Although, causality cannot be directly confirmed, it is apparent that ample water intake in children, above and beyond the body's compensatory mechanisms, is preferable for psychological and physiological health. However, the prevalence of failure to meet water recommendations and hypohydration in children remains high. Still it is unclear if elevated hypohydration reports within the pediatric population are due to a general failure of children to meet water recommendations, or due to inadequacy of the published guidelines

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,454Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Kids 3-13 y		Healthy boys and girls of 3-13 y of age
Parents 20-50 y		One of their Parents 20-50 y of age

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urine Hydration Biomarkers	24 h urine osmolality (mmol/kg water) for children (3-13 y) and one of their parents's	May 2019

Secondary Outcomes

Measure	Description	Time Frame
Physical Activity	Physical activity levels assessed by the International Physical Activity Questionnaire for both kids and parents, expressed as MET-min/week	May 2019
Anthropometric Assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

Boys and girls aged 3-13 years old
Parent willing to participate as a subject as well
Parents: aged 20-50
Children and parents willing to collect urine samples and store them at room temperature
Avoid strenuous exercise on day of collection
Parent: included if >50% of grocery shopping, food preparation, and feeding is handled by this parent

EXCLUSION CRITERIA:

Parents & Children:

Evidence of clinically relevant metabolic, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrine or psychiatric history of disease, based on the medical history questionnaire
Use of medication that interferes with water metabolism
Surgical operation on digestive tract (e.g. bariatric surgery), except possible appendectomy
Regular drug treatment within 15 days prior to start of the study
Not willing to refrain from exercise on the day before and during urine collection
Unwilling to collect urine
Inability to participate in the entire study
Pregnancy for females

Children:

Use of Diapers
Enuresis or use of nappies during the day or during the night

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Children (3-13 y) and their Parents (20-50 y)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Stavros A Kavouras, PhD	Arizona State University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arizona State University		Phoenix	Arizona	85004	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42248249	Derived	Seal AD, Suh H, Emmanuel H, Colburn AT, Summers L, Bottin J, Zemdegs J, Vanhaecke T, Mauromoustakos A, Kavouras SA. Hydration and Water Intake among Children and Parents. J Nutr. 2026 Jun 4:101643. doi: 10.1016/j.tjnut.2026.101643. Online ahead of print.

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes