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

Bronchiolitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355043
• Other study ID #: 2005-027
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2006
• Last updated: July 11, 2011
• Start date: February 2006
• Est. completion date: September 2007

Study information

• Verified date: July 2006
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 23 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• Zinc sulphate 20 mg

Locations

Country	Name	City	State
Bangladesh	ICDDR,B	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	United States Agency for International Development (USAID)

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of zinc on the duration of bronchiolitis in children
Secondary	Effect of Zinc
Secondary	The severity of bronchiolitis.
Secondary	The rate of hospitalization.
Secondary	Future episodes of wheezing.