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

Terminated

• Conditions: Dehydration

• Registration Number: NCT02937038
• Lead Sponsor: Arizona State University

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

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-18
• Primary Completion: 2020-03-31
• Study Completion: 2021-06-25
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1454

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States