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

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ClinicalTrials.gov Identifier: NCT01571856
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : May 7, 2013
Sponsor:
Information provided by (Responsible Party):
Giuseppe Grandy, Centro Pediatrico Albina de Patino

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Acute Diarrhea Acute Gastroenteritis Drug: Zinc Sulfate Other: placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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.
Study Start Date : July 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. duration of hospitalization [ Time Frame: 5 days ]
    participants will be followed for the duration of hospital stay, an expected average of 5 days

  2. weight of stool [ Time Frame: 5 days ]
    we expected the weight of the stool will diminish by about 5 days


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

Inclusion Criteria:

  • all acute diarrhea

Exclusion Criteria:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • coinfections
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571856


Locations
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Bolivia
Centro Pediatrico Albina Patino
Cochabamba, Bolivia
Sponsors and Collaborators
Centro Pediatrico Albina de Patino
Investigators
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Study Director: Giuseppe Grandy, MD MSc Centro Pediatrico Albina de Patino
Study Chair: Zaida Cama, MD Centro Pediatrico Albina Ptino
More Information
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Responsible Party: Giuseppe Grandy, Medical Chief of Nutrition Center, Centro Pediatrico Albina de Patino
ClinicalTrials.gov Identifier: NCT01571856    
Other Study ID Numbers: protzinc2012
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013
Keywords provided by Giuseppe Grandy, Centro Pediatrico Albina de Patino:
Acute Diarrhea
Zinc
Children
Additional relevant MeSH terms:
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Gastroenteritis
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Digestive System Diseases
 Zinc Sulfate
Astringents
Physiological Effects of Drugs
Dermatologic Agents