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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02937038
Acronym
HYBISKUS
Enrollment
1454
Registered
2016-10-18
Start date
2016-06-30
Completion date
2021-06-25
Last updated
2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration

Keywords

Urine Biomarkers, Child Nutrition, Hydration, Parent Nutrition Habits

Brief summary

Purpose: 1. Develop reference values for hydration biomarkers for children of 3 to 13 years old 2. Explore the association between children's and parents' hydration markers and fluid intake habits in children aged 3-13 y 3. Evaluate the equivalence of spot urine osmolality to 24h urine osmolality in children aged 3-13 y 4. Evaluate the differences in hydration markers between school and non-school days in children aged 3-13 y 5. 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

Interventions

None listed

Sponsors

Danone Global Research & Innovation Center
CollaboratorINDUSTRY
Arizona State University
Lead SponsorOTHER

Study design

Observational model
FAMILY_BASED
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
3 Years to 13 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Urine Hydration BiomarkersMay 201924 h urine osmolality (mmol/kg water) for children (3-13 y) and one of their parents's

Secondary

MeasureTime frameDescription
Physical ActivityMay 2019Physical activity levels assessed by the International Physical Activity Questionnaire for both kids and parents, expressed as MET-min/week
Anthropometric AssessmentMay 2019Body mass index (kg/m2)
Socioeconomic AssessmentMay 2019Family information for: Income ($) Ethnicity Education Employment status
Water intakeMay 2019Dietary water intake (L)
Energy intakeMay 2019Caloric Intake (kcal)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026