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

Phase 4

Completed

• Conditions: Acute Diarrhea; Acute Gastroenteritis
• Interventions: Other: placebo; Drug: Zinc Sulfate

• Registration Number: NCT01571856
• Lead Sponsor: Centro Pediatrico Albina de Patino

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-05
• Primary Completion: 2012-07
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-05
• Last Update Posted: 2013-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• all acute diarrhea

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Exclusion Criteria

• Severe malnourishment
• Severe dehydration
• Systemic infections
• coinfections

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cornstarch solution	placebo	cornstarch powder diluted in distilled water
zinc sulfate	Zinc Sulfate	zinc sulphate solution.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centro Pediatrico Albina Patino; 🇧🇴 Cochabamba, Bolivia