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

Dehydration Clinical Trial

— HYBISKUS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02937038
• Other study ID #: 16-02-574
• Status: Terminated
• Start date: June 2016
• Est. completion date: June 25, 2021

Study information

• Verified date: July 2021
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1454
• Est. completion date: June 25, 2021
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Dehydration

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Danone Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine Hydration Biomarkers	24 h urine osmolality (mmol/kg water) for children (3-13 y) and one of their parents's	May 2019
Secondary	Physical Activity	Physical activity levels assessed by the International Physical Activity Questionnaire for both kids and parents, expressed as MET-min/week	May 2019
Secondary	Anthropometric Assessment	Body mass index (kg/m2)	May 2019
Secondary	Socioeconomic Assessment	Family information for: Income ($) Ethnicity Education Employment status	May 2019
Secondary	Water intake	Dietary water intake (L)	May 2019
Secondary	Energy intake	Caloric Intake (kcal)	May 2019