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

NCT00355043 | Completed Phase 3

• 1 other identifier: 2005-027
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

Zinc treatment; Bronchiolitis; Wheezing; Children aged 2 months to 23 months; Diagnosed case of acute bronchiolitis

Outcome Measures

Primary Outcomes (1)

• Effect of zinc on the duration of bronchiolitis in children

Secondary Outcomes (4)

• Effect of Zinc

• The severity of bronchiolitis.

• The rate of hospitalization.

• Future episodes of wheezing.

Interventions

Zinc sulphate 20 mg DRUG

Eligibility Criteria

• Age: 2 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

ICDDR,B

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Bronchiolitis; Respiratory Sounds

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Dilruba Nasrin, MBBS,PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2006
• First Posted: July 21, 2006
• Study Start: February 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: July 12, 2011

Record last verified: 2006-07

Locations

BA (1)