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

• ClinicalTrials.gov Identifier: NCT00355043
• Recruitment Status: Completed
• First Posted: July 21, 2006
• Last Update Posted: July 12, 2011
• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Collaborator: United States Agency for International Development (USAID)
• Information provided by: International Centre for Diarrhoeal Disease Research, Bangladesh

Tracking Information

• First Submitted Date: July 20, 2006
• First Posted Date: July 21, 2006
• Last Update Posted Date: July 12, 2011
• Study Start Date: February 2006
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 20, 2006): Effect of zinc on the duration of bronchiolitis in children
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 20, 2006)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Zinc in the Treatment of Bronchiolitis and Prevention of Wheezing Respiratory Illness in Children Less Than Two Years Old
• Official Title: Not Provided
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Bronchiolitis
• Intervention: Drug: Zinc sulphate 20 mg
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: July 20, 2006): 330
• Original Enrollment: Same as current
• Actual Study Completion Date: September 2007
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Months to 23 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bangladesh

Administrative Information

• NCT Number: NCT00355043
• Other Study ID Numbers: 2005-027
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Principal Investigator, International Centre for Diarrhoeal Disease Resarch, Bangladesh
• Study Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Collaborators: United States Agency for International Development (USAID)

Investigators

• Principal Investigator: Dilruba Nasrin, MBBS,PhD; International Centre for Diarrhoeal Disease Research, Bangladesh

• PRS Account: International Centre for Diarrhoeal Disease Research, Bangladesh
• Verification Date: July 2006