NCT01571856

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

Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Under Six Months.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Centro Pediatrico Albina de Patino · Academic / Other
• Sex: All
• Age: 1 Month – 6 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Acute Diarrhea
• Acute Gastroenteritis

Interventions

Type	Name	Description
DRUG	Zinc Sulfate	zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day.
OTHER	placebo	cornstarch powder diluted in distilled water, dosage 2.5 ml per day

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-07-01
• Completion: 2013-05-01
• First posted: 2012-04-05
• Last updated: 2013-05-07

Locations

1 site across 1 country: Bolivia