Palatability of Oral Rehydration Solutions

NCT ID: NCT00689312

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-08-31

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.

Conditions

Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Enfalyte

Intervention Type: DRUG

Each patient will receive one 250 ml dose.

2

Group Type: EXPERIMENTAL

Pediatric Electrolyte

Intervention Type: DRUG

Each patient will receive one 250 ml dose.

3

Group Type: EXPERIMENTAL

Pedialyte

Intervention Type: DRUG

Each patient will receive one 250 ml dose.

Interventions

Enfalyte

Each patient will receive one 250 ml dose.

Intervention Type: DRUG

Pediatric Electrolyte

Each patient will receive one 250 ml dose.

Intervention Type: DRUG

Pedialyte

Each patient will receive one 250 ml dose.

Intervention Type: DRUG

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Stephen Freedman

Adjunct Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Freedman, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 20679159 (View on PubMed)

Other Identifiers

1000012122

Identifier Type: -

Identifier Source: org_study_id