Efficacy of Zinc in the Treatment of Pneumonia

• Sponsor: Johns Hopkins Bloomberg School of Public Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT00198666
• Collaborator: (none)
• Enrollment: 299
• Arms: 2
• Duration (Months): 11

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Drug: Zinc	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 299 participants
• 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
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Aug 1, 2004
• Actual Study Completion Date: Aug 1, 2004

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Duration of severe symptoms [2 years]

Secondary Outcome Measures

1. Time to recovery from severe pneumonia [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 23 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• children under two years old hospitalized with Pneumonia

Exclusion Criteria:

• healthy children

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Johns Hopkins Bloomberg School of Public Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mathuram Santosham, Professor, Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT00198666
• Other Study ID Numbers: H.22.03.01.06.A2
• First Posted: Sep 20, 2005
• Last Update Posted: Jan 12, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Mathuram Santosham, Professor, Johns Hopkins Bloomberg School of Public Health: Pneumonia; zinc
• Additional relevant MeSH terms: Pneumonia

Study Results

No Results Posted as of Jan 12, 2015