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

Centro Pediatrico Albina de Patino

Status and phase: Completed; Phase 4

Conditions: Acute Gastroenteritis; Acute Diarrhea

Treatments: Other: placebo; Drug: Zinc Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT01571856

protzinc2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 1 to 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all acute diarrhea

Exclusion criteria

• Severe malnourishment
• Severe dehydration
• Systemic infections
• coinfections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

zinc sulfate

Active Comparator group

Description:

zinc sulphate solution.

Treatment:

Drug: Zinc Sulfate

cornstarch solution

Placebo Comparator group

Description:

cornstarch powder diluted in distilled water

Treatment:

Other: placebo