Palatability of Oral Rehydration Solutions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephen Freedman, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00689312
First received: May 29, 2008
Last updated: December 10, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Mean taste scores for Pedialyte, Pediatric Electrolyte, and Enfalyte. [ Time Frame: Immediately following consumption of each solution. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689312

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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: Stephen Freedman, Adjunct Scientist, 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: December 10, 2013
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 September 14, 2014