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Efficacy of Zinc in the Treatment of Bronchiolitis and Prevention of Wheezing Respiratory Illness in Children Less Than Two Years Old

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Phase 3
Locations
Bangladesh
Study Type
Interventional
Intervention
Zinc sulphate 20 mg
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Zinc treatment, Bronchiolitis, Wheezing, Children aged 2 months to 23 months, Diagnosed case of acute bronchiolitis

Eligibility Criteria

2 Months - 23 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children 2 months to 23 months old at the time of clinical diagnosis· Episode of wheezing for the first time Written consent· Who do not require hospitalization at the time of diagnosis Exclusion Criteria: History of asthma Chronic cardiac or respiratory disease (e.g.cyanotic heart disease -ASD) History of previous wheezing or bronchodilator therapy Gestational age at birth <34 weeks Suspected tuberculosis, active measles Any illness (severe malnutrition, sepsis, meningitis) that requires hospitalisation Who had zinc/placebo supplements during this study· H/o zinc intake within last 3 months· Whose caretakers withhold consent

Sites / Locations

  • ICDDR,B

Outcomes

Primary Outcome Measures

Effect of zinc on the duration of bronchiolitis in children

Secondary Outcome Measures

Effect of Zinc
The severity of bronchiolitis.
The rate of hospitalization.
Future episodes of wheezing.

Full Information

First Posted
July 20, 2006
Last Updated
July 11, 2011
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
United States Agency for International Development (USAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00355043
Brief Title
Efficacy of Zinc in the Treatment of Bronchiolitis and Prevention of Wheezing Respiratory Illness in Children Less Than Two Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
United States Agency for International Development (USAID)

4. Oversight

5. Study Description

Brief Summary
1. Bronchiolitis is a leading cause of morbidity and mortality in children. It is an acute, infectious illness of the lower respiratory tract resulting in obstruction of the bronchioles. The etiology is viral in the majority of the cases and RSV is the most commonly isolated agent. The disease is more common in younger children under 2 years of age. Children often receive unnecessary antibiotics and often require hospitalization. An episode of bronchiolitis can be followed by recurrent wheezing episodes. RSV bronchiolitis in the first year of life is one of the most important risk factors for the subsequent development of asthma in both developed and developing countries. Thus, bronchiolitis is a global public health problem. Zinc supplementation has been shown to be effective in both preventing and treating pneumonia. However, no study has particularly examined the effect of zinc on ARI associated with wheezing. This study aims to investigate whether zinc (20 mg/day) reduces1. the duration of bronchiolitis in children.2. the severity of bronchiolitis in children.3. the rate of hospitalization for bronchiolitis.3. future episodes of wheezing in children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Zinc treatment, Bronchiolitis, Wheezing, Children aged 2 months to 23 months, Diagnosed case of acute bronchiolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zinc sulphate 20 mg
Primary Outcome Measure Information:
Title
Effect of zinc on the duration of bronchiolitis in children
Secondary Outcome Measure Information:
Title
Effect of Zinc
Title
The severity of bronchiolitis.
Title
The rate of hospitalization.
Title
Future episodes of wheezing.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children 2 months to 23 months old at the time of clinical diagnosis· Episode of wheezing for the first time Written consent· Who do not require hospitalization at the time of diagnosis Exclusion Criteria: History of asthma Chronic cardiac or respiratory disease (e.g.cyanotic heart disease -ASD) History of previous wheezing or bronchodilator therapy Gestational age at birth <34 weeks Suspected tuberculosis, active measles Any illness (severe malnutrition, sepsis, meningitis) that requires hospitalisation Who had zinc/placebo supplements during this study· H/o zinc intake within last 3 months· Whose caretakers withhold consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilruba Nasrin, MBBS,PhD
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICDDR,B
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Zinc in the Treatment of Bronchiolitis and Prevention of Wheezing Respiratory Illness in Children Less Than Two Years Old

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