Effectiveness of Oral Rehydration Therapy Supplemented With Zinc in the Management of Diarrhea Acute

November 9, 2015 updated by: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Effectiveness of Oral Rehydration Therapy Supplemented With Zinc in the Management of Diarrhea Acute in Mexican Children: Randomized Double-blind Study

Acute diarrhea is the third cause of infant mortality in the world causing 15% of all deaths in children under 5 years and is responsible for nearly 1.4 million deaths in developing countries. It is considered a self-limiting disease and to this problem the recommendation of the World Health Organization (WHO) is the administration of zinc with low osmolarity oral dehydration salts for a period of 10-14 days which reduces the severity of the episode.

In Mexico COFEPRIS believes the zinc salt as a food supplement and not a drug and the above problem is presented in terms of prescribing and access of this salt to the general population. In Mexico the investigators have the provision and accessibility of low osmolarity oral dehydration salts supplemented with adequate doses of zinc, which is inexpensive for the general population and offering a solution in terms of supply and management.

The purpose of the study involves the evaluation Pedialyte diarrhea in the treatment of acute diarrhea in children under 5 years. The investigator sconsider the use of Pedialyte diarrhea eases their access to the population in general and it is low cost compared with the zinc salt that is sold only in specialized pharmacies under strict medical prescription Objective: Compare the duration of symptoms of acute diarrhea in the treatment with low osmolarity oral rehydration salts (Pedialyte) vs treatment of low osmolarity oral rehydration supplemented with zinc (Pedialyte diarrhea) Study Desing: Double blind, randomized, controlled.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It will be conducted a randomized controlled double-blind in the Emergency service of the Naval General Hospital of High Specialty in the Mexico City. The period of patient inclusion in the study is October 2015 to November 2016.

The patients selections is the children between 6 months and 5 years who come to the emergency room with symptoms of acute diarrhea with up to 48 hours of starting the disease, it will proceed to questioning and to assess vital signs and thorough physical examination for determine the degree of dehydration, nutritional status and rule out diagnosis of abdominal pathology emergency.

Selection criteria Inclusion

  • Patients 6 months to 5 years old with acute diarrhea
  • Patients in their first 48 hours of onset diarrhea
  • Dehydration mild to moderate according to WHO clinical scale
  • Both sexes
  • Outpatients

Exclusion

  • Patients with vomit (10 or more)
  • Hemodynamic Instability
  • Dehydration severe
  • Patients with heart disease
  • Patients with a history of prematurity.
  • Patients with chronic diarrhea
  • Patients whose parents refuse to provide written informed consent
  • Patients who do not comply with treatment correctly
  • Patients with suspected surgical pathology

Elimination

  • Patients with severe dehydration
  • Patients in whom the parents decline for informed consent

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 6 months to 5 years old with acute diarrhea
  • Patients in their first 48 hours of onset diarrhea
  • Dehydration mild to moderate according to WHO clinical scale
  • Both sexes
  • Outpatients

Exclusion Criteria:

  • Patients with vomit (10 or more)
  • Hemodynamic Instability
  • Severe dehydration
  • Patients with heart disease
  • Patients with a history of prematurity.
  • Patients with chronic diarrhea
  • Patients whose parents refuse to provide written informed consent
  • Patients who do not comply with treatment correctly
  • Patients with suspected surgical pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Zinc group
Pedialyte diarrhea oral electrolyte solution, 330 ml per day for 7 days
Other: Zinc group
Pedialyte diarrhea oral electrolyte solution, 330 ml per day for 7 days
Other Names:
  • Pedialyte diarrhea 45
Placebo Comparator: Placebo group
Pedialyte oral electrolyte solution, 330 ml per day for 7 days
Other: Placebo group
Pedialyte oral electrolyte solution, 330 ml per day for 7 days
Other Names:
  • Pedialyte SR 45

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of bowel movements per day
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Investigators

  • Principal Investigator: María del Carmen Yebra Cano, Medicina, Secretaria de Marina-Armada de México (Mexican Navy)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

November 9, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGNAE-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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