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

NCT ID: NCT01571856

Last Updated: 2013-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-05-31

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.

Conditions

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Acute Diarrhea Acute Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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zinc sulfate

zinc sulphate solution.

Group Type ACTIVE_COMPARATOR

Zinc Sulfate

Intervention Type DRUG

zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day.

cornstarch solution

cornstarch powder diluted in distilled water

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

cornstarch powder diluted in distilled water, dosage 2.5 ml per day

Interventions

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Zinc Sulfate

zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day.

Intervention Type DRUG

placebo

cornstarch powder diluted in distilled water, dosage 2.5 ml per day

Intervention Type OTHER

Other Intervention Names

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Suplizinc

Eligibility Criteria

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Inclusion Criteria

* all acute diarrhea

Exclusion Criteria

* Severe malnourishment
* Severe dehydration
* Systemic infections
* coinfections
Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Pediatrico Albina de Patino

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Grandy

Medical Chief of Nutrition Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Grandy, MD MSc

Role: STUDY_DIRECTOR

Centro Pediatrico Albina de Patino

Zaida Cama, MD

Role: STUDY_CHAIR

Centro Pediatrico Albina Ptino

Locations

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Centro Pediatrico Albina Patino

Cochabamba, Departamento de Cochabamba, Bolivia

Site Status

Countries

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Bolivia

Other Identifiers

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protzinc2012

Identifier Type: -

Identifier Source: org_study_id

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