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

Primary Purpose

Gastroenteritis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Gatorade, Pedialyte and New Solution
Sponsored by
Augusta University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteritis

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 21, 2005
Last Updated
January 8, 2014
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT00257374
Brief Title
Pedialyte or Gatorade for Viral Gastroenteritis in Adults: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University

4. Oversight

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gatorade, Pedialyte and New Solution

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish SC Rao, MD,PhD, FRCP(LON)
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Gastroenterology & Infectious Disease, Osmania Medical College
City
Hyderabad
ZIP/Postal Code
500012
Country
India

12. IPD Sharing Statement

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

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