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Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants

Primary Purpose

Acute Diarrhea, Acute Gastroenteritis

Status
Completed
Phase
Phase 4
Locations
Bolivia
Study Type
Interventional
Intervention
Zinc Sulfate
placebo
Sponsored by
Centro Pediatrico Albina de Patino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Diarrhea focused on measuring Acute Diarrhea, Zinc, Children

Eligibility Criteria

1 Month - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all acute diarrhea

Exclusion Criteria:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • coinfections

Sites / Locations

  • Centro Pediatrico Albina Patino

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

zinc sulfate

cornstarch solution

Arm Description

zinc sulphate solution.

cornstarch powder diluted in distilled water

Outcomes

Primary Outcome Measures

duration of diarrheal episode
duration of diarreal episode, time in wich the watery stools will be normalized, an expected average of 5 days.

Secondary Outcome Measures

duration of hospitalization
participants will be followed for the duration of hospital stay, an expected average of 5 days
weight of stool
we expected the weight of the stool will diminish by about 5 days

Full Information

First Posted
April 3, 2012
Last Updated
May 5, 2013
Sponsor
Centro Pediatrico Albina de Patino
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1. Study Identification

Unique Protocol Identification Number
NCT01571856
Brief Title
Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants
Official Title
Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Under Six Months.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Pediatrico Albina de Patino

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of zinc in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.
Detailed Description
Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, today exist strong evidence of beneficial effect of use of zinc in acute diarrhea in children over 6 months. but there are not enough clinical trials to show this beneficial effect on children under 6 months. Objectives: To evaluate the effect of zinc in the treatment of children under 6 months age with acute diarrhea. Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive zinc plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of diarrhea stools by day, weight of stool, nutritional state.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diarrhea, Acute Gastroenteritis
Keywords
Acute Diarrhea, Zinc, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zinc sulfate
Arm Type
Active Comparator
Arm Description
zinc sulphate solution.
Arm Title
cornstarch solution
Arm Type
Placebo Comparator
Arm Description
cornstarch powder diluted in distilled water
Intervention Type
Drug
Intervention Name(s)
Zinc Sulfate
Other Intervention Name(s)
Suplizinc
Intervention Description
zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
cornstarch powder diluted in distilled water, dosage 2.5 ml per day
Primary Outcome Measure Information:
Title
duration of diarrheal episode
Description
duration of diarreal episode, time in wich the watery stools will be normalized, an expected average of 5 days.
Time Frame
five days
Secondary Outcome Measure Information:
Title
duration of hospitalization
Description
participants will be followed for the duration of hospital stay, an expected average of 5 days
Time Frame
5 days
Title
weight of stool
Description
we expected the weight of the stool will diminish by about 5 days
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all acute diarrhea Exclusion Criteria: Severe malnourishment Severe dehydration Systemic infections coinfections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Grandy, MD MSc
Organizational Affiliation
Centro Pediatrico Albina de Patino
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zaida Cama, MD
Organizational Affiliation
Centro Pediatrico Albina Ptino
Official's Role
Study Chair
Facility Information:
Facility Name
Centro Pediatrico Albina Patino
City
Cochabamba
Country
Bolivia

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants

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