Back to resultsZinc Supplementation and Severe and Recurrent Diarrhea
Primary Purpose
Diarrhea
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Zinc Supplement
Sponsored by
About this trial
This is an interventional prevention trial for Diarrhea focused on measuring Zinc Supplement, Diarrhea, Sever Diarrhea
Eligibility Criteria
Inclusion Criteria:
- All 6 to 36 months old children without diarrhea at the time of study and without disease such as celiac
- Inflammatory bowl disease and hypersensitivity to milk
Exclusion Criteria:
- Diarrhea at the time of the study and background disease such as celiac, IBD or hypersensitivity to milk
Sites / Locations
- Hormozgan University of medical sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zinc sulfate
Arm Description
daily zinc supplementation for 3 months. (10mg daily for under 1 years old children and 20mg daily for above 1 years old children)
Outcomes
Primary Outcome Measures
Diarrhea
Incidence, Duration and frequency
Secondary Outcome Measures
Admission for diarrhea
Total number of admissions during the study period
Full Information
NCT ID
NCT01306097
First Posted
February 28, 2011
Last Updated
February 28, 2011
Sponsor
Hormozgan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01306097
Brief Title
Zinc Supplementation and Severe and Recurrent Diarrhea
Official Title
Evaluating the Impact of 3 Months Daily Zinc Supplementation on Incidence of Severe and Recurrent Diarrhea in 6 to 36 Months Age Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hormozgan University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and recurrent diarrhea in 6 to 36 months age children in Bandarabbaas
Detailed Description
Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and recurrent diarrhea in 6 to 36 months age children in Bandarabbaas in 2009
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
Zinc Supplement, Diarrhea, Sever Diarrhea
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zinc sulfate
Arm Type
Experimental
Arm Description
daily zinc supplementation for 3 months. (10mg daily for under 1 years old children and 20mg daily for above 1 years old children)
Intervention Type
Drug
Intervention Name(s)
Zinc Supplement
Other Intervention Name(s)
Zinc sulfate, Oral Zinc
Intervention Description
10mg daily for under 1 years old children and 20mg daily for above 1 years old children
Primary Outcome Measure Information:
Title
Diarrhea
Description
Incidence, Duration and frequency
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Admission for diarrhea
Description
Total number of admissions during the study period
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All 6 to 36 months old children without diarrhea at the time of study and without disease such as celiac
Inflammatory bowl disease and hypersensitivity to milk
Exclusion Criteria:
Diarrhea at the time of the study and background disease such as celiac, IBD or hypersensitivity to milk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marzie Barchinejad
Organizational Affiliation
Hormozgan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hormozgan University of medical sciences
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
79145-3388
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Zinc Supplementation and Severe and Recurrent Diarrhea
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