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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

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

Tracking Information
First Submitted Date  ICMJE July 20, 2006
First Posted Date  ICMJE July 21, 2006
Last Update Posted Date July 12, 2011
Study Start Date  ICMJE February 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2006)
Effect of zinc on the duration of bronchiolitis in children
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2006)
  • Effect of Zinc
  • The severity of bronchiolitis.
  • The rate of hospitalization.
  • Future episodes of wheezing.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Zinc in the Treatment of Bronchiolitis and Prevention of Wheezing Respiratory Illness in Children Less Than Two Years Old
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Bronchiolitis
Intervention  ICMJE Drug: Zinc sulphate 20 mg
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 20, 2006)
330
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 23 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00355043
Other Study ID Numbers  ICMJE 2005-027
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Principal Investigator, International Centre for Diarrhoeal Disease Resarch, Bangladesh
Study Sponsor  ICMJE International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators  ICMJE United States Agency for International Development (USAID)
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP