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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giuseppe Grandy, Centro Pediatrico Albina de Patino
ClinicalTrials.gov Identifier:
NCT01571856
First received: April 3, 2012
Last updated: May 5, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • duration of diarrheal episode [ Time Frame: five days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    participants will be followed for the duration of hospital stay, an expected average of 5 days

  • weight of stool [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   1 Month to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all acute diarrhea

Exclusion Criteria:

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

Locations
Bolivia
Centro Pediatrico Albina Patino
Cochabamba, Bolivia
Sponsors and Collaborators
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
  More Information

No publications provided

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

Keywords provided by Centro Pediatrico Albina de Patino:
Acute Diarrhea
Zinc
Children

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Zinc
Zinc Sulfate
 Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013