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Efficacy of Zinc in the Treatment of Pneumonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00198666
First Posted: September 20, 2005
Last Update Posted: January 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mathuram Santosham, Johns Hopkins Bloomberg School of Public Health
  Purpose
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.

Condition Intervention
Pneumonia Drug: Zinc

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Zinc in the Treatment of Pneumonia in Hospitalized Children Less Than 2 Years of Age

Resource links provided by NLM:


Further study details as provided by Mathuram Santosham, Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Duration of severe symptoms [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Time to recovery from severe pneumonia [ Time Frame: 2 years ]

Enrollment: 299
Study Start Date: September 2003
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Children with severe pneumonia were randomly assigned to receive supplementation with elemental zinc.
Drug: Zinc
Elemental Zinc
No Intervention: Control
Children with severe pneumonia were randomly assigned to receive supplementation with placebo tablets.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children under two years old hospitalized with Pneumonia

Exclusion Criteria:

  • healthy children
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198666


Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Mathuram Santosham, MD Johns Hopkins Bloomberg School of Public Health
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mathuram Santosham, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00198666     History of Changes
Other Study ID Numbers: H.22.03.01.06.A2
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: January 12, 2015
Last Verified: January 2015

Keywords provided by Mathuram Santosham, Johns Hopkins Bloomberg School of Public Health:
Pneumonia
zinc

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs