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Zinc Supplementation Versus Placebo for Bronchiolitis Management in Children: A Comparative Study

Protocol summary

Study aim
To evaluate the efficacy of zinc supplementation compared to a placebo in augmenting standard therapy for the management of bronchiolitis in pediatric patients.
Design
Single blind randomized controlled trial
Settings and conduct
The study was conducted in the patients admitted in Children hospital and university of child health sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria Children with age group 2 - 23 months having and Clinical signs & symptoms of acute bronchiolitis were included Exclusion criteria Children with use of mechanical ventilation in neonates or History of prematurity, Recent use of antibiotic, Congenital heart and lung disease, Down syndrome, Respiratory failure signs, Immunodeficiency, Previous wheezing episodes history, Family history of allergies and/or asthma, Metabolic or neurological diseases, Zinc intake during the previous one month were excluded
Intervention groups
One group received 1% zinc sulphate (20mg/5ml) orally (0.5 cc/kg in children with age below one year and 5cc (20 mg) in children with age above 1 year). Other group received placebo treatment (5%-100% glucose water and oral flavoring). General appearance, smell, color and taste of the Zinc and placebo syrups was similar.
Main outcome variables
Patients were evaluated for the clinical sign & symptoms including wheezing, rhinorrhea, cyanosis, subcostal and intercostal retraction, tachypnea, fever and nasal flaring. pre-designed Performa was sued to record findings.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230729058959N1
Registration date: 2023-09-14, 1402/06/23
Registration timing: retrospective

Last update: 2023-09-14, 1402/06/23
Update count: 0
Registration date
2023-09-14, 1402/06/23
Registrant information
Name
Hafiz sheraz Arshad
Name of organization / entity
Link Medical Institute-The Journal of Health and Rehabilitation Research (JHRR)
Country
Pakistan
Phone
+92 300 4009429
Email address
editor@jhrlmc.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-15, 1401/09/24
Expected recruitment end date
2023-05-30, 1402/03/09
Actual recruitment start date
2022-12-15, 1401/09/24
Actual recruitment end date
2023-06-15, 1402/03/25
Trial completion date
2023-06-15, 1402/03/25
Scientific title
Zinc Supplementation Versus Placebo for Bronchiolitis Management in Children: A Comparative Study
Public title
Zinc Supplementation Versus Placebo for Bronchiolitis Management in Children: A Comparative Study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with age group 2 - 23 months having Clinical signs & symptoms of acute bronchiolitis
Exclusion criteria:
Use of mechanical ventilation in neonates or History of prematurity Recent use of antibiotic Congenital heart and lung disease Down syndrome Respiratory failure signs Immunodeficiency Previous wheezing episodes history Family history of allergies and/or asthma Metabolic or neurological diseases Zinc intake during the previous one month
Age
From 2 months old to 23 months old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
Sample size
Target sample size: 102
Actual sample size reached: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Single blind randomized controlled trial
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blind randomized controlled trial
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Review Board
Street address
Saeed Ahmad Awan Mohallah Qasorian Qila Didar Singh Gujranwala
City
Gujranwala
Postal code
50250
Approval date
2022-08-20, 1401/05/29
Ethics committee reference number
576

Health conditions studied

1

Description of health condition studied
Bronchiolitis
ICD-10 code
J21
ICD-10 code description
Acute bronchiolitis

Primary outcomes

1

Description
wheezing
Timepoint
24, 48, 72, 96 and 120 hours
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Children hospital and university of child health sciences
Full name of responsible person
Dr. Ali Hamza Arshad
Street address
Children hospital and university of child health sciences
City
Lahore
Postal code
54000
Phone
+92 333 4379801
Email
Drhamzaarshad92@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Children hospital and university of child health sciences
Full name of responsible person
Dr Ali Hamza Arshad
Street address
Children hospital and university of child health sciences
City
Lahore
Postal code
54000
Phone
+92 333 4379801
Email
Drhamzaarshad92@gmail.com
Grant name
NA-Self
Grant code / Reference number
NA-Self
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Children hospital and university of child health sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Children hospital and university of child health sciences
Full name of responsible person
Dr Ali Hamza Arshad
Position
Medical Officer
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Children hospital and university of child health sciences
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 4379801
Email
Drhamzaarshad92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Children hospital and university of child health sciences
Full name of responsible person
Dr Ali Hamza Arshad
Position
Medical Officer
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Children hospital and university of child health sciences
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 4379801
Email
Drhamzaarshad92@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Children hospital and university of child health sciences
Full name of responsible person
Dr Ali Hamza Arshad
Position
Medical Officer
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
Children hospital and university of child health sciences
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 4379801
Email
Drhamzaarshad92@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
NA
When the data will become available and for how long
NA
To whom data/document is available
NA
Under which criteria data/document could be used
NA
From where data/document is obtainable
NA
What processes are involved for a request to access data/document
NA
Comments
NA
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