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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

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Drug: Zinc sulphate 20 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Effect of zinc on the duration of bronchiolitis in children

Secondary Outcome Measures :
  1. Effect of Zinc
  2. The severity of bronchiolitis.
  3. The rate of hospitalization.
  4. Future episodes of wheezing.


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Ages Eligible for Study:   2 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355043


Locations
Bangladesh
ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Dilruba Nasrin, MBBS,PhD International Centre for Diarrhoeal Disease Research, Bangladesh

Responsible Party: Principal Investigator, International Centre for Diarrhoeal Disease Resarch, Bangladesh
ClinicalTrials.gov Identifier: NCT00355043     History of Changes
Other Study ID Numbers: 2005-027
First Posted: July 21, 2006    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: July 2006

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Zinc treatment
Bronchiolitis
Wheezing
Children aged 2 months to 23 months
Diagnosed case of acute bronchiolitis

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Astringents
Dermatologic Agents