Palatability of Oral Rehydration Solutions
Primary Purpose
Gastroenteritis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Enfalyte
Pediatric Electrolyte
Pedialyte
Sponsored by
About this trial
This is an interventional other trial for Gastroenteritis focused on measuring Gastroenteritis, Pediatrics, Rehydration therapy
Eligibility Criteria
Inclusion Criteria:
- Children 5-10 years of age evaluated in The Hospital for Sick Children's emergency department
Exclusion Criteria:
- 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
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Mean taste scores for Pedialyte, Pediatric Electrolyte, and Enfalyte.
Secondary Outcome Measures
Proportions of children who indicate a taste preference for one of the solutions.
Full Information
NCT ID
NCT00689312
First Posted
May 29, 2008
Last Updated
April 16, 2018
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT00689312
Brief Title
Palatability of Oral Rehydration Solutions
Official Title
Palatability of Oral Rehydration Solutions
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
In Canada, acute gastroenteritis remains a major cause of morbidity and hospitalizations. This, in large part, is due to an inability to realize the full benefits of oral rehydration therapy. Because oral rehydration solutions have a salty taste, many mild to moderate dehydrated children refuse to drink them. This has resulted in pediatricians recommending inappropriate solutions and the unnecessary administration of intravenous fluids. Although two meta-analyses have concluded that rice-based ORS (Enfalyte) is as or more effective than traditional ORS in reducing stool output, the palatability of different oral rehydration solutions have never been evaluated.
This will be the first prospective trial comparing the palatability of the most commonly recommended oral rehydration solutions, Pedialyte and Enfalyte with a newer solution, Pediatric Electrolyte. Both Pedialyte and Pediatric Electrolyte contain sucralose, dextrose, and fructose while Enfalyte contains rice syrup solids. Although the latter is as, or more effective than Pedialyte in reducing stool output, palatability may limit its use. Taste is important as children with gastroenteritis are frequently nauseated and may refuse to drink or vomit when consuming less palatable solutions.
We hypothesize that, compared to children who receive a rice-based ORS (Enfalyte), those who receive a sucralose ORS (Pediatric Electrolyte or Pedialyte) will report a higher mean taste score, will prefer to drink the sucralose sweetened ORS if they had to consume a larger volume, and are more likely to drink the entire volume they are provided.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis
Keywords
Gastroenteritis, Pediatrics, Rehydration therapy
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Enfalyte
Intervention Description
Each patient will receive one 250 ml dose.
Intervention Type
Drug
Intervention Name(s)
Pediatric Electrolyte
Intervention Description
Each patient will receive one 250 ml dose.
Intervention Type
Drug
Intervention Name(s)
Pedialyte
Intervention Description
Each patient will receive one 250 ml dose.
Primary Outcome Measure Information:
Title
Mean taste scores for Pedialyte, Pediatric Electrolyte, and Enfalyte.
Time Frame
Immediately following consumption of each solution.
Secondary Outcome Measure Information:
Title
Proportions of children who indicate a taste preference for one of the solutions.
Time Frame
Immediately following consumption of each solution.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children 5-10 years of age evaluated in The Hospital for Sick Children's emergency department
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Freedman, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
20679159
Citation
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.
Results Reference
derived
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Palatability of Oral Rehydration Solutions
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