Acute Gastroenteritis Clinical Trial
Official title:
Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Under Six Months.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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