Clinical trial NCT02937038: Reference Values and Determinants of Hydration in Children 3-13 y
Official title: Reference Values and Determinants of Hydration in Children 3-13 y
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dehydration
Keywords: Urine Biomarkers
Child Nutrition
Hydration
Parent Nutrition Habits
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Danone Global Research & Innovation Center
First posted: 2016-10-18
Enrollment: 1454
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children (3-13 y) and their Parents (20-50 y)

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

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

Primary outcomes:
measure: Urine Hydration Biomarkers
timeFrame: May 2019
Secondary outcomes:
measure: Physical Activity
timeFrame: May 2019
measure: Anthropometric Assessment
timeFrame: May 2019
measure: Socioeconomic Assessment
timeFrame: May 2019
measure: Water intake
timeFrame: May 2019
measure: Energy intake
timeFrame: May 2019
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Stavros A Kavouras, PhD
role: PRINCIPAL_INVESTIGATOR
References: