Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants
|ClinicalTrials.gov Identifier: NCT01571856|
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : May 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Diarrhea Acute Gastroenteritis||Drug: Zinc Sulfate Other: placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Under Six Months.|
|Study Start Date :||July 2011|
|Primary Completion Date :||July 2012|
|Study Completion Date :||May 2013|
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
- duration of diarrheal episode [ Time Frame: five days ]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 ]participants will be followed for the duration of hospital stay, an expected average of 5 days
- weight of stool [ Time Frame: 5 days ]we expected the weight of the stool will diminish by about 5 days
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|