Efficacy of Zinc in the Treatment of Pneumonia

NCT ID: NCT00198666

Last Updated: 2015-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment

Children with severe pneumonia were randomly assigned to receive supplementation with elemental zinc.

Group Type EXPERIMENTAL

Zinc

Intervention Type DRUG

Elemental Zinc

Control

Children with severe pneumonia were randomly assigned to receive supplementation with placebo tablets.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Zinc

Elemental Zinc

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* children under two years old hospitalized with Pneumonia

Exclusion Criteria

* healthy children
Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Mathuram Santosham

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mathuram Santosham, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

References

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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. doi: 10.1093/ajcn/86.2.397.

Reference Type DERIVED
PMID: 17684211 (View on PubMed)

Other Identifiers

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H.22.03.01.06.A2

Identifier Type: -

Identifier Source: org_study_id

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