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

Acute Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571856
• Other study ID #: protzinc2012
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2012
• Last updated: May 5, 2013
• Start date: July 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Centro Pediatrico Albina de Patino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bolivia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 6 Months

Eligibility

Inclusion Criteria:

• all acute diarrhea

Exclusion Criteria:

• Severe malnourishment

• Severe dehydration

• Systemic infections

• coinfections

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Diarrhea
• Acute Gastroenteritis
• Diarrhea
• Gastroenteritis

Intervention

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

Locations

Country	Name	City	State
Bolivia	Centro Pediatrico Albina Patino	Cochabamba

Sponsors (1)

Lead Sponsor	Collaborator
Centro Pediatrico Albina de Patino

Country where clinical trial is conducted

Bolivia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of diarrheal episode	duration of diarreal episode, time in wich the watery stools will be normalized, an expected average of 5 days.	five days	Yes
Secondary	duration of hospitalization	participants will be followed for the duration of hospital stay, an expected average of 5 days	5 days	Yes
Secondary	weight of stool	we expected the weight of the stool will diminish by about 5 days	5 days	Yes