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Behavioural Intervention

Flavored Rehydration Drink for Childhood Dehydration (ROAR Trial)

N/A

Recruiting

Research Sponsored by Arizona State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Girls and boys age 8 to 10 years

Body weight ≤85th percentile for their age group

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 2, and 3 hour

Awards & highlights

ROAR Trial Summary

This trial aims to find out if adding flavor to low-sugar water can increase and improve hydration for kids who exercise.

Who is the study for?

This trial is for boys and girls aged 8 to 10 who are willing to exercise in a warm environment. They must have a body weight within the normal range (≤85th percentile) for their age group. Children with conditions affecting water balance, previous heat stroke, disabilities preventing moderate exercise, or those on medications influencing hydration cannot participate.Check my eligibility

What is being tested?

The study tests if flavored water with less sugar helps children stay more hydrated compared to plain water during multiple bouts of exercise over three hours. It aims to see if taste can encourage kids to drink enough fluids while being active.See study design

What are the potential side effects?

Since this trial involves rehydration with plain or flavored water, there are minimal expected side effects. However, some children might experience mild gastrointestinal discomfort from drinking large amounts of fluid quickly.

ROAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 8 and 10 years old.

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My weight is in the normal range for my age.

ROAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 2, and 3 hour

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 2, and 3 hour

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, and 3 hour for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fluid intake during the 3 hour period

Net Fluid Balance based on body weight changes

Secondary outcome measures

Urine osmotic excretion

Urine output

urine osmolality

ROAR Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Low Carb drinkExperimental Treatment1 Intervention

Roaring Water

Group II: WaterPlacebo Group1 Intervention

Plain Water

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor

283 Previous Clinical Trials

109,490 Total Patients Enrolled

Kraft Heinz CompanyIndustry Sponsor

2 Previous Clinical Trials

81 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any eligibility criteria that would preclude my participation in this trial?

"To partake in this clinical trial, children aged 8 to 10 with a history of dehydration must apply. As such, the total enrollment size is expected to be 24 participants."

Answered by AI

Does this investigation accept volunteers who are aged over eighty-five?

"This clinical trial demands that applicants are between 8 and 10 years old. Additionally, there are 5 studies for minors below the legal age of consent and another 8 dedicated to elderly participants over 65."

Answered by AI

What is the current enrollment rate of this research study?

"Affirmative. Per the information provided on clinicaltrials.gov, this research trial is still searching for participants - first posted in October 6th 2023 and last updated 12 days later. The aim is to recruit 24 patients from a solitary medical centre."

Answered by AI

Is this trial currently enrolling participants?

"Affirmative. The clinicaltrials.gov database indicates that this research project, which was announced on October 6th 2023, is actively recruiting participants. Approximately 24 patients must be sourced from 1 medical establishment to complete the study's goals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Children Rehydration During Exercise

2023. "Children Rehydration During Exercise". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06084702.

All > Dehydration