DehydrationHYBISKUSNCT02937038
Reference Values and Determinants of Hydration in Children 3-13 y
An observational study of Dehydration, run by Arizona State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- How many people
- 1,454 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 25 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children (3-13 y) and their Parents (20-50 y)
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Purpose:
- Develop reference values for hydration biomarkers for children of 3 to 13 years old
- Explore the association between children's and parents' hydration markers and fluid intake habits in children aged 3-13 y
- Evaluate the equivalence of spot urine osmolality to 24h urine osmolality in children aged 3-13 y
- Evaluate the differences in hydration markers between school and non-school days in children aged 3-13 y
- Examine the role of different foods and fluids on hydration in children (3-13 y) and parents
Read the 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
- Conditions
- Dehydration
- Keywords
- Urine Biomarkers, Child Nutrition, Hydration, Parent Nutrition Habits
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Hydration Biomarkers
24 h urine osmolality (mmol/kg water) for children (3-13 y) and one of their parents's
Measured: May 2019
Secondary outcomes (5)
Physical Activity
Physical activity levels assessed by the International Physical Activity Questionnaire for both kids and parents, expressed as MET-min/week
Measured: May 2019
Anthropometric Assessment
Body mass index (kg/m2)
Measured: May 2019
Socioeconomic Assessment
Family information for:
Income ($) Ethnicity Education Employment status
Measured: May 2019
Water intake
Dietary water intake (L)
Measured: May 2019
Energy intake
Caloric Intake (kcal)
Measured: May 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJun 2016
- Primary completion31 Mar 2020
- Study completion25 Jun 2021
Why it stopped: COVID-19 difficulties recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 1,454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Principal investigator, Stavros Kavouras, Arizona State University
- Investigators
- Stavros A Kavouras, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937038
- Sponsor's protocol ID
- 16-02-574
- Acronym
- HYBISKUS
- Status last verified
- Jul 2021
- First submitted
- 12 Oct 2016
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual report for nutrition and hydration information will be provided to the volunteers
Publications
Seal AD, Suh H, Emmanuel H, Colburn AT, Summers L, Bottin J, Zemdegs J, Vanhaecke T, Mauromoustakos A, Kavouras SA. Hydration and Water Intake among Children and Parents. J Nutr. 2026 Aug;156(8):101643. doi: 10.1016/j.tjnut.2026.101643. Epub 2026 Jun 4.
PubMed 42248249
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Values and Determinants of Hydration in Children 3-13 y
- ClinicalTrials.gov ID
- NCT02937038
- Acronym / sponsor ID
- HYBISKUS / 16-02-574
- Conditions
- Dehydration
- Keywords
- Urine Biomarkers, Child Nutrition, Hydration, Parent Nutrition Habits
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 difficulties recruiting
- Enrolment
- 1,454 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- Jun 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose:
- Develop reference values for hydration biomarkers for children of 3 to 13 years old
- Explore the association between children's and parents' hydration markers and fluid intake habits in children aged 3-13 y
- Evaluate the equivalence of spot urine osmolality to 24h urine osmolality in children aged 3-13 y
- Evaluate the differences in hydration markers between school and non-school days in children aged 3-13 y
- 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 design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children (3-13 y) and their Parents (20-50 y)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urine Hydration Biomarkers
Time frame: May 2019
24 h urine osmolality (mmol/kg water) for children (3-13 y) and one of their parents's
5 secondary outcomes
Physical Activity
Time frame: May 2019
Anthropometric Assessment
Time frame: May 2019
Socioeconomic Assessment
Time frame: May 2019
Water intake
Time frame: May 2019
Energy intake
Time frame: May 2019
Results and safety
The study was stopped early (reason given: COVID-19 difficulties recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Derived from this study: PubMed 42248249Seal AD, Suh H, Emmanuel H, Colburn AT, Summers L, Bottin J, Zemdegs J, Vanhaecke T, Mauromoustakos A, Kavouras SA. Hydration and Water Intake among Children and Parents. J Nutr. 2026 Aug;156(8):101643. doi: 10.1016/j.tjnut.2026.101643. Epub 2026 Jun 4.
- Individual participant dataSharing planned: Yes. Individual report for nutrition and hydration information will be provided to the volunteers
Related trials for Dehydration
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Not yet recruitingPhase 2
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
Recruiting
Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
Obesity & Overweight, Type 2 Diabetes
Recruiting
Hydration & Female Life Stages
Dehydration, Menstruation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stavros A Kavouras, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 difficulties recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Hydration Biomarkers (time frame: May 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02937038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.