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Sponsored by: |
The Hospital for Sick Children |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00689312 |
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 |
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Gastroenteritis |
Drug: Enfalyte Drug: Pediatric Electrolyte Drug: Pedialyte |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment |
Official Title: | Palatability of Oral Rehydration Solutions |
Estimated Enrollment: | 66 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Enfalyte
Each patient will receive one 250 ml dose.
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2: Experimental |
Drug: Pediatric Electrolyte
Each patient will receive one 250 ml dose.
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3: Experimental |
Drug: Pedialyte
Each patient will receive one 250 ml dose.
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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.
Ages Eligible for Study: | 5 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephen Freedman, MD | 416-813-7654 ext 2382 | stephen.freedman@sickkids.ca |
Contact: Deborah Atchison | 416-813-5418 | deborah.atchison@sickkids.ca |
Canada, Ontario | |
The Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada | |
Contact: Stephen Freedman 416-813-7654 ext 2382 stephen.freedman@sickkids.ca | |
Principal Investigator: Stephen Freedman, MD | |
Sub-Investigator: Suzanne Schuh, MD | |
Sub-Investigator: Kathy Boutis, MD |
Principal Investigator: | Stephen Freedman, MD | The Hospital for Sick Children |
Responsible Party: | The Hospital for Sick Children ( Stephen Freedman/Principal Investigator ) |
Study ID Numbers: | 1000012122 |
Study First Received: | May 29, 2008 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00689312 |
Health Authority: | Canada: Ethics Review Committee |
Gastroenteritis Pediatrics Rehydration therapy |
Digestive System Diseases Gastrointestinal Diseases Gastroenteritis |