Efficacy of Zinc in the Treatment of Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mathuram Santosham, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00198666
First received: September 12, 2005
Last updated: January 9, 2015
Last verified: January 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Duration of severe symptoms [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to recovery from severe pneumonia [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
Other Name: 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

Ages Eligible for Study:   up to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children under two years old hospitalized with Pneumonia

Exclusion Criteria:

  • healthy children
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional 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
Study First Received: September 12, 2005
Last Updated: January 9, 2015
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 27, 2015