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

This study has been completed.
Information provided by (Responsible Party):
Giuseppe Grandy, Centro Pediatrico Albina de Patino Identifier:
First received: April 3, 2012
Last updated: May 5, 2013
Last verified: May 2013
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.

Condition Intervention Phase
Acute Diarrhea
Acute Gastroenteritis
Drug: Zinc Sulfate
Other: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Under Six Months.

Resource links provided by NLM:

Further study details as provided by Centro Pediatrico Albina de Patino:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Enrollment: 52
Study Start Date: July 2011
Study Completion Date: May 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: placebo
cornstarch powder diluted in distilled water, dosage 2.5 ml per day

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.


Ages Eligible for Study:   1 Month to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • all acute diarrhea

Exclusion Criteria:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • coinfections
  Contacts and Locations
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Please refer to this study by its identifier: NCT01571856

Centro Pediatrico Albina Patino
Cochabamba, Bolivia
Sponsors and Collaborators
Centro Pediatrico Albina de Patino
Study Director: Giuseppe Grandy, MD MSc Centro Pediatrico Albina de Patino
Study Chair: Zaida Cama, MD Centro Pediatrico Albina Ptino
  More Information

Responsible Party: Giuseppe Grandy, Medical Chief of Nutrition Center, Centro Pediatrico Albina de Patino Identifier: NCT01571856     History of Changes
Other Study ID Numbers: protzinc2012
Study First Received: April 3, 2012
Last Updated: May 5, 2013

Keywords provided by Centro Pediatrico Albina de Patino:
Acute Diarrhea

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Zinc Sulfate
Physiological Effects of Drugs
Dermatologic Agents
Trace Elements
Growth Substances processed this record on May 25, 2017