NCT00198666

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

January 12, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

September 12, 2005

Last Update Submit

January 9, 2015

Conditions

Pneumonia

Keywords

Pneumoniazinc

Outcome Measures

Primary Outcomes (1)

  • Duration of severe symptoms

    2 years

Secondary Outcomes (1)

  • Time to recovery from severe pneumonia

    2 years

Study Arms (2)

Treatment

EXPERIMENTAL

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

Drug: Zinc

Control

NO INTERVENTION

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

Interventions

ZincDRUG

Elemental Zinc

Treatment

Eligibility Criteria

AgeUp to 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children under two years old hospitalized with Pneumonia

You may not qualify if:

  • healthy children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17684211DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Zinc

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Mathuram Santosham, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 1, 2003

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

January 12, 2015

Record last verified: 2015-01