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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2011/07/001864 |
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Date of registration:
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07-07-2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Role of zinc supplementation in promoting recovery from acute bronchiolitis (a viral respiratory tract infection) in children.
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Scientific title:
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ZINC SUPPLEMENTATION FOR SEVERE BRONCHIOLITIS: A RANDOMIZED CONTROLLED STUDY |
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Date of first enrolment:
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01-05-2010 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=1603 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
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Phase:
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Phase 4
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Dheeraj Shah
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Address:
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Department of Pediatrics, UCMS & GTB Hospital Dilshad Garden
110095
New Delhi, DELHI
India |
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Telephone:
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09868399792 |
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Email:
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shahdheeraj@hotmail.com |
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Affiliation:
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Department of Pediatrics, University College of Medical Sciences and Guru Tegh Bahadur Hospital |
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Name:
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Dr Dheeraj Shah
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Address:
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Department of Pediatrics, University College of Medical Sciences and Guru Tegh Bahadur Hospital, Dilshad Garden
110095
New Delhi, DELHI
India |
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Telephone:
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09868399792 |
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Email:
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shahdheeraj@hotmail.com |
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Affiliation:
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Department of Pediatrics, University College of Medical Sciences and Guru Tegh Bahadur Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: Children (between 3 months to 2 years) with a clinical diagnosis of severe bronchiolitis (inability to feed, severe distress,apnea, hypoxemia, lethargy or cyanosis)
Exclusion criteria: 1) They were receiving or had received any micronutrient supplementation within last 4 weeks prior to onset of present illness.
2) Clinical evidence of underlying cardiac or chronic pulmonary disease
3) There is a co-morbid condition (severe malnutrition, meningitis) present at the time of admission.
4) There is lobar consolidation in chest x-ray.
5) Intubation/ventilation is required before enrolment.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: J219- Acute bronchiolitis, unspecified
Health Condition 2: null- Bronchiolitis
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Intervention(s)
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Intervention1: oral zinc: 10 mg/day for children 6 months; 20 mg/day for children 6 months
Duration: 7 days
Control Intervention1: Placebo: Identically looking and packaged inert tablets for 7 days
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Primary Outcome(s)
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1. Resolution of severe bronchiolitis (when lower chest retraction and the danger signs are no longer present)
2. Time to resolution of lower chest indrawing, fast breathing, inability to feed
Timepoint: 7 days
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Secondary Outcome(s)
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1. Recovery rate (proportion of children with resolution of severe bronchiolitis)
2. Duration of oxygen therapy
3. Duration of IV fluids
4. Duration of hospitalization
Timepoint: 7 days
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Source(s) of Monetary Support
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Pharmed Limited
Pharmed Gardens
Whitefield Road
Bangalore 560048
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Ethics review
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Status: Approved
Approval date: 14/11/2009
Contact:
Institutional Ethics Committee- Human Research (University College of Medical Sciences), Delhi
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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