Palatability of Oral Rehydration Solutions

Gastroenteritis Clinical Trial

Official title:

Palatability of Oral Rehydration Solutions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689312
• Other study ID #: 1000012122
• Status: Completed
• Phase: Phase 3
• First received: May 29, 2008
• Last updated: April 16, 2018
• Start date: May 2008
• Est. completion date: August 2008

Study information

• Verified date: April 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroenteritis

Intervention

Drug:
• Enfalyte
Each patient will receive one 250 ml dose.
• Pediatric Electrolyte
Each patient will receive one 250 ml dose.
• Pedialyte
Each patient will receive one 250 ml dose.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean taste scores for Pedialyte, Pediatric Electrolyte, and Enfalyte.		Immediately following consumption of each solution.
Secondary	Proportions of children who indicate a taste preference for one of the solutions.		Immediately following consumption of each solution.