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Completed

NCT Number: NCT00689312

Palatability of Oral Rehydration Solutions

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.

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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enfalyte

Drug

Each patient will receive one 250 ml dose.

Pediatric Electrolyte

Drug

Each patient will receive one 250 ml dose.

Pedialyte

Drug

Each patient will receive one 250 ml dose.

Primary outcomes

  1. Mean taste scores for Pedialyte, Pediatric Electrolyte, and Enfalyte.

    Time frame: Immediately following consumption of each solution.

Secondary outcomes

  1. Proportions of children who indicate a taste preference for one of the solutions.

    Time frame: Immediately following consumption of each solution.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 3, 2008
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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