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.

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.

Study Overview

• Status: Completed
• Conditions: Acute Gastroenteritis; Acute Diarrhea
• Intervention / Treatment: Drug: Zinc Sulfate; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bolivia
  • Cochabamba, Bolivia
    • Centro Pediatrico Albina Patino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all acute diarrhea

Exclusion Criteria:

• Severe malnourishment
• Severe dehydration
• Systemic infections
• coinfections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Suplizinc
Placebo Comparator: cornstarch solution; cornstarch powder diluted in distilled water	Other: placebo; cornstarch powder diluted in distilled water, dosage 2.5 ml per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of hospitalization	participants will be followed for the duration of hospital stay, an expected average of 5 days	5 days
weight of stool	we expected the weight of the stool will diminish by about 5 days	5 days

Collaborators and Investigators

• Sponsor: Centro Pediatrico Albina de Patino
• Investigators: Study Director: Giuseppe Grandy, MD MSc, Centro Pediatrico Albina de Patino; Study Chair: Zaida Cama, MD, Centro Pediatrico Albina Ptino

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: April 3, 2012
• First Submitted That Met QC Criteria: April 4, 2012
• First Posted (Estimate): April 5, 2012

Study Record Updates

• Last Update Posted (Estimate): May 7, 2013
• Last Update Submitted That Met QC Criteria: May 5, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Children; Zinc; Acute Diarrhea
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Diarrhea; Gastroenteritis; Physiological Effects of Drugs; Dermatologic Agents; Astringents; Zinc Sulfate
• Other Study ID Numbers: protzinc2012