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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01571856
Other study ID # protzinc2012
Secondary ID
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


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
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