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

September 12, 2005
January 9, 2015
September 2003
August 2004   (final data collection date for primary outcome measure)
Duration of severe symptoms [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Duration of severe symptoms
Complete list of historical versions of study NCT00198666 on ClinicalTrials.gov Archive Site
Time to recovery from severe pneumonia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Time to recovery from severe pneumonia
Not Provided
Not Provided
 
Efficacy of Zinc in the Treatment of Pneumonia
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Pneumonia
Drug: Zinc
Elemental Zinc
Other Name: Zinc
  • Experimental: Treatment
    Children with severe pneumonia were randomly assigned to receive supplementation with elemental zinc.
    Intervention: Drug: Zinc
  • No Intervention: Control
    Children with severe pneumonia were randomly assigned to receive supplementation with placebo tablets.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
299
August 2004
August 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • children under two years old hospitalized with Pneumonia

Exclusion Criteria:

  • healthy children
Both
up to 23 Months
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00198666
H.22.03.01.06.A2
No
Mathuram Santosham, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
Not Provided
Principal Investigator: Mathuram Santosham, MD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP