Pedialyte or Gatorade for Viral Gastroenteritis in Adults: a Randomized, Controlled Trial

Background: Pedialyte and Gatorade are advocated for the treatment of dehydration in viral gastroenteritis, but there is limited evidence to support their use.

Objective: To examine the efficacy, safety and palatability of Pedialyte, Gatorade, and a New Oral Rehydration Solution (NS).

Design: Randomized double blind. Setting: Inpatient, community hospital. Patients/Interventions: 75 consecutive adult patients (m/f=44/33) admitted with viral gastroenteritis were randomized to receive Gatorade, Pedialyte or NS for 48 hours. A yogurt/rice diet was allowed ad libitum.

Measurements: Stool and urine output, electrolytes, fluid intake, body weight, hematocrit and palatability of solutions.

Limitations: Smaller sample size and higher drop out (20%).

Study Overview

• Status: Completed
• Conditions: Gastroenteritis
• Intervention / Treatment: Drug: Gatorade, Pedialyte and New Solution

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Hyderabad, India, 500012
    • Dept. of Gastroenterology & Infectious Disease, Osmania Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects were included if they had mild-to-moderate diarrhea, with mildly sunken eyes and a clinical assessment of dehydration of less than 5%, a serum sodium concentration between 130-150 mEq/L, adequate general health and nutrition, a BUN/creatinine ratio of >20 and with a normal pulse rate for age and degree of fever and adequate skin turgor

Exclusion Criteria:

• Patients were excluded if they had hyperthermia (>39.0º C), serum sodium >150 mEq/L or <130 mEq/L, white cell count >15,000, bloody diarrhea (dysentery), abnormal cardiovascular or renal function or an underlying metabolic or nutritional disorder and most importantly, if the clinical assessment of dehydration was >7% that suggested a need for intravenous fluids.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Augusta University
• Investigators: Principal Investigator: Satish SC Rao, MD,PhD, FRCP(LON), University of Iowa

Study record dates

Study Registration Dates

• First Submitted: November 21, 2005
• First Submitted That Met QC Criteria: November 21, 2005
• First Posted (Estimate): November 22, 2005

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: Gatorade