NCT00689312

Brief Summary

The primary objective of this study is to compare the mean taste scores for three fruit flavored oral rehydration solutions in children aged 5-10 years old. The secondary objective is to compare the proportions of children who indicate a taste preference for one of the solutions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

3 months

First QC Date

May 29, 2008

Last Update Submit

April 16, 2018

Conditions

Gastroenteritis

Keywords

GastroenteritisPediatricsRehydration therapy

Outcome Measures

Primary Outcomes (1)

  • Mean taste scores for Pedialyte, Pediatric Electrolyte, and Enfalyte.

    Immediately following consumption of each solution.

Secondary Outcomes (1)

  • Proportions of children who indicate a taste preference for one of the solutions.

    Immediately following consumption of each solution.

Study Arms (3)

1

ACTIVE COMPARATOR
Drug: Enfalyte

2

EXPERIMENTAL
Drug: Pediatric Electrolyte

3

EXPERIMENTAL
Drug: Pedialyte

Interventions

EnfalyteDRUG

Each patient will receive one 250 ml dose.

1
Pediatric ElectrolyteDRUG

Each patient will receive one 250 ml dose.

2
PedialyteDRUG

Each patient will receive one 250 ml dose.

3

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 5-10 years of age evaluated in The Hospital for Sick Children's emergency department

You may not qualify if:

  • Children with diarrhea, a vomiting or diarrhea episode within 24 hours, head trauma, abdominal pain, upper respiratory symptoms, or nil per os status
  • Patients with gastrointestinal symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Freedman SB, Cho D, Boutis K, Stephens D, Schuh S. Assessing the palatability of oral rehydration solutions in school-aged children: a randomized crossover trial. Arch Pediatr Adolesc Med. 2010 Aug;164(8):696-702. doi: 10.1001/archpediatrics.2010.129.

    PMID: 20679159DERIVED

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Stephen Freedman, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Scientist

Study Record Dates

First Submitted

May 29, 2008

First Posted

June 3, 2008

Study Start

May 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

CA(1)