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

Phase 3

Completed

• Conditions: Bronchiolitis

• Registration Number: NCT00355043
• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Status Verified: 2006-07
• Study First Submitted: 2006-07-20
• Study First Submitted QC: 2006-07-20
• Study First Posted: 2006-07-21
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Last Update Submitted: 2011-07-11
• Last Update Posted: 2011-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of zinc on the duration of bronchiolitis in children

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ICDDR,B; 🇧🇩 Dhaka, Bangladesh