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

Sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval (Other)
Overall Status
Unknown status
CT.gov ID
NCT02601742
Collaborator
(none)
350
Enrollment
2
Arms
12
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Zinc group
  • Other: Placebo group
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Oral Rehydration Therapy Supplemented With Zinc in the Management of Diarrhea Acute in Mexican Children: Randomized Double-blind Study
Study Start Date :
Nov 1, 2015
Anticipated Primary Completion Date :
Jan 1, 2016
Anticipated Study Completion Date :
Nov 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of bowel movements per day [4 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • 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)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Hospital General Naval de Alta Especialidad - Escuela Medico Naval
    ClinicalTrials.gov Identifier:
    NCT02601742
    Other Study ID Numbers:
    • HGNAE-09
    First Posted:
    Nov 10, 2015
    Last Update Posted:
    Nov 10, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Hospital General Naval de Alta Especialidad - Escuela Medico Naval
    zinc
    Duration
    Additional relevant MeSH terms:
    Diarrhea

    Study Results

    No Results Posted as of Nov 10, 2015