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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Under Six Months.

Conditions
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Acute Diarrhea, Acute Gastroenteritis

Intervention / Treatment
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* Drug: Zinc Sulfate
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all acute diarrhea Exclusion Criteria: Severe malnourishment Severe dehydration Systemic infections coinfections

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: zinc sulfate<br>zinc sulphate solution. | Drug: Zinc Sulfate<br>* zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day.<br>* Other names: Suplizinc;|
| Placebo Comparator: cornstarch solution<br>cornstarch powder diluted in distilled water | Other: placebo<br>* cornstarch powder diluted in distilled water, dosage 2.5 ml per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of diarrheal episode | duration of diarreal episode, time in wich the watery stools will be normalized, an expected average of 5 days. | five days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of hospitalization | participants will be followed for the duration of hospital stay, an expected average of 5 days | 5 days | 
| weight of stool | we expected the weight of the stool will diminish by about 5 days | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zinc, Children, Acute Diarrhea