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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Satish Rao, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00257374
First received: November 21, 2005
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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 Intervention
Gastroenteritis
Drug: Gatorade, Pedialyte and New Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257374

Locations
India
Dept. of Gastroenterology & Infectious Disease, Osmania Medical College
Hyderabad, India, 500012
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: Satish SC Rao, MD,PhD, FRCP(LON) University of Iowa
  More Information

No publications provided

Responsible Party: Satish Rao, Professor, Georgia Regents University
ClinicalTrials.gov Identifier: NCT00257374     History of Changes
Other Study ID Numbers: Gatorade
Study First Received: November 21, 2005
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 23, 2014