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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00257374
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : January 9, 2014
Information provided by (Responsible Party):
Satish Rao, Augusta University

Brief Summary:

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%).

Condition or disease Intervention/treatment Phase
Gastroenteritis Drug: Gatorade, Pedialyte and New Solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00257374

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Dept. of Gastroenterology & Infectious Disease, Osmania Medical College
Hyderabad, India, 500012
Sponsors and Collaborators
Augusta University
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Principal Investigator: Satish SC Rao, MD,PhD, FRCP(LON) University of Iowa
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Responsible Party: Satish Rao, Professor, Augusta University Identifier: NCT00257374    
Other Study ID Numbers: Gatorade
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases