Efficacy of Zinc in the Treatment of Pneumonia
Primary Purpose
Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Zinc
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring Pneumonia, zinc
Eligibility Criteria
Inclusion Criteria: children under two years old hospitalized with Pneumonia Exclusion Criteria: healthy children
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Children with severe pneumonia were randomly assigned to receive supplementation with elemental zinc.
Children with severe pneumonia were randomly assigned to receive supplementation with placebo tablets.
Outcomes
Primary Outcome Measures
Duration of severe symptoms
Secondary Outcome Measures
Time to recovery from severe pneumonia
Full Information
NCT ID
NCT00198666
First Posted
September 12, 2005
Last Updated
January 9, 2015
Sponsor
Johns Hopkins Bloomberg School of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT00198666
Brief Title
Efficacy of Zinc in the Treatment of Pneumonia
Official Title
Efficacy of Zinc in the Treatment of Pneumonia in Hospitalized Children Less Than 2 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to evaluate the efficacy of zinc supplementation in the treatment of children under the age of two years who have been hospitalized with severe pneumonia.
Detailed Description
This study was a randomized, double-blind, placebo-controlled clinical trial conducted between September 2003 and August 2004 at the Christian Medical College (CMC) Hospital in Vellore, India. CMC Hospital is a large teaching hospital and medical center that is accessed directly by the population of Vellore and adjoining districts and by referrals from local medical practitioners.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Pneumonia, zinc
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
299 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Children with severe pneumonia were randomly assigned to receive supplementation with elemental zinc.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Children with severe pneumonia were randomly assigned to receive supplementation with placebo tablets.
Intervention Type
Drug
Intervention Name(s)
Zinc
Intervention Description
Elemental Zinc
Primary Outcome Measure Information:
Title
Duration of severe symptoms
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Time to recovery from severe pneumonia
Time Frame
2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children under two years old hospitalized with Pneumonia
Exclusion Criteria:
healthy children
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathuram Santosham, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
17684211
Citation
Coles CL, Bose A, Moses PD, Mathew L, Agarwal I, Mammen T, Santosham M. Infectious etiology modifies the treatment effect of zinc in severe pneumonia. Am J Clin Nutr. 2007 Aug;86(2):397-403. doi: 10.1093/ajcn/86.2.397.
Results Reference
derived
Learn more about this trial
Efficacy of Zinc in the Treatment of Pneumonia
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