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Efficacy of Zinc in the Treatment of Pneumonia

Primary Purpose

Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Zinc
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Pneumonia, zinc

Eligibility Criteria

undefined - 23 Months (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 12, 2005
    Last Updated
    January 9, 2015
    Sponsor
    Johns Hopkins Bloomberg School of Public Health
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    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

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    Efficacy of Zinc in the Treatment of Pneumonia

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