Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants
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.
Drug: Zinc Sulfate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Under Six Months.|
- duration of diarrheal episode [ Time Frame: five days ] [ Designated as safety issue: Yes ]duration of diarreal episode, time in wich the watery stools will be normalized, an expected average of 5 days.
- duration of hospitalization [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]participants will be followed for the duration of hospital stay, an expected average of 5 days
- weight of stool [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]we expected the weight of the stool will diminish by about 5 days
|Study Start Date:||July 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Active Comparator: zinc sulfate
zinc sulphate solution.
Drug: Zinc Sulfate
zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day.
Other Name: Suplizinc
Placebo Comparator: cornstarch solution
cornstarch powder diluted in distilled water
cornstarch powder diluted in distilled water, dosage 2.5 ml per day
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571856
|Centro Pediatrico Albina Patino|
|Study Director:||Giuseppe Grandy, MD MSc||Centro Pediatrico Albina de Patino|
|Study Chair:||Zaida Cama, MD||Centro Pediatrico Albina Ptino|