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

NCT02937038 | Terminated

• 1 other identifier: 16-02-574
• Study Type: observational
• Target: 1,454
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose:

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

Conditions

Dehydration

Keywords

Urine Biomarkers; Child Nutrition; Hydration; Parent Nutrition Habits

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• Physical Activity

  May 2019

• Anthropometric Assessment

  May 2019

• Socioeconomic Assessment

  May 2019

• Water intake

  May 2019

• Energy intake

  May 2019

Study Arms (2)

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

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stavros A Kavouras, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 18, 2016
• Study Start: June 1, 2016
• Primary Completion: March 31, 2020
• Study Completion: June 25, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)