Efficacy of Zinc in the Treatment of Pneumonia

January 9, 2015 updated by: Mathuram Santosham, Johns Hopkins Bloomberg School of Public Health

Efficacy of Zinc in the Treatment of Pneumonia in Hospitalized Children Less Than 2 Years of Age

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

299

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children under two years old hospitalized with Pneumonia

Exclusion Criteria:

  • healthy children

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of severe symptoms
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to recovery from severe pneumonia
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Investigators

  • Principal Investigator: Mathuram Santosham, MD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2015

Last Update Submitted That Met QC Criteria

January 9, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H.22.03.01.06.A2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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