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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

April 3, 2012
May 5, 2013
July 2011
July 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01571856 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Diarrhea
  • Acute Gastroenteritis
  • Drug: Zinc Sulfate
    zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day.
    Other Name: Suplizinc
  • Other: placebo
    cornstarch powder diluted in distilled water, dosage 2.5 ml per day
  • Active Comparator: zinc sulfate
    zinc sulphate solution.
    Intervention: Drug: Zinc Sulfate
  • Placebo Comparator: cornstarch solution
    cornstarch powder diluted in distilled water
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
May 2013
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all acute diarrhea

Exclusion Criteria:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections
  • coinfections
Both
1 Month to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
Bolivia
 
NCT01571856
protzinc2012
No
Giuseppe Grandy, Centro Pediatrico Albina de Patino
Centro Pediatrico Albina de Patino
Not Provided
Study Director: Giuseppe Grandy, MD MSc Centro Pediatrico Albina de Patino
Study Chair: Zaida Cama, MD Centro Pediatrico Albina Ptino
Centro Pediatrico Albina de Patino
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP