Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants
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|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|
|Actual Primary Completion Date :||July 2012|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|