Palatability of Oral Rehydration Solutions
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroenteritis |
Drug: Enfalyte Drug: Pediatric Electrolyte Drug: Pedialyte |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Palatability of Oral Rehydration Solutions |
- Mean taste scores for Pedialyte, Pediatric Electrolyte, and Enfalyte. [ Time Frame: Immediately following consumption of each solution. ] [ Designated as safety issue: No ]
- Proportions of children who indicate a taste preference for one of the solutions. [ Time Frame: Immediately following consumption of each solution. ] [ Designated as safety issue: No ]
| Enrollment: | 66 |
| Study Start Date: | May 2008 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Enfalyte
Each patient will receive one 250 ml dose.
|
| Experimental: 2 |
Drug: Pediatric Electrolyte
Each patient will receive one 250 ml dose.
|
| Experimental: 3 |
Drug: Pedialyte
Each patient will receive one 250 ml dose.
|
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.
Eligibility| Ages Eligible for Study: | 5 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada | |
| Principal Investigator: | Stephen Freedman, MD | The Hospital for Sick Children |
More Information
No publications provided by The Hospital for Sick Children
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00689312 History of Changes |
| Other Study ID Numbers: | 1000012122 |
| Study First Received: | May 29, 2008 |
| Last Updated: | November 28, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by The Hospital for Sick Children:
|
Gastroenteritis Pediatrics Rehydration therapy |
Additional relevant MeSH terms:
|
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013