Comparing the effect of Zinc gluconate and placebo in the treatment of tachypnea, dyspnea and fever in children aged 2-23 months with acute bronchiolitis
The objective of this randomized, double-blind clinical trial is evaluation of effect of zinc gluconate in the treatment of children aged between 2-23 months with acute bronchiolitis.
Design
In this double-blind randomized controlled clinical trial with a parallel group, 100 children with acute bronchiolitis will be divided into two groups randomly.
Settings and conduct
In this double-blind study, personal information’s, clinical signs and symptoms and laboratory findings of the patients will be recorded in prearranged forms at the time of admission. Zinc gluconate 1% syrup will be prescribed for the case group and a placebo solution will be prescribed for the control group . Clinical signs and symptoms of patients such as coryza, cough, fever, tachypnea, etc were recorded at 0, 24, 72 hours and 7 days after the beginning of the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 2 to 23 months; first episode of wheezing following the viral infection of the upper respiratory tract; presence of clinical manifestations of acute bronchiolitis; absence of consolidation on the chest x-ray. Exclusion criteria: patients with history of more than one episode of wheezing; history of asthma and allergy in the patients and their family; congenital heart disease; malnutrition and pneumonia; low birth weight and intrauterine growth retardation (IUGR); previous antibiotic therapy.
Intervention groups
Intervention group: Zinc gluconate 1% syrup, Control group: Placebo solution. children younger than 1 year of age will receive 10 mg Zinc gluconate 1% or placebo solution in two divided doses and those over the age of 1 year will receive 20 mg in two divided doses. The drugs will be administered for 5 days.
Main outcome variables
Tachypnea; dyspnea; fever
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160318027097N12
Registration date:2018-11-28, 1397/09/07
Registration timing:registered_while_recruiting
Last update:2018-11-28, 1397/09/07
Update count:0
Registration date
2018-11-28, 1397/09/07
Registrant information
Name
ِDr Faramarz Darghahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2000
Email address
mj.naghizadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Zinc gluconate and placebo in the treatment of tachypnea, dyspnea and fever in children aged 2-23 months with acute bronchiolitis
Public title
Effect of zinc gluconate on acute bronchiolitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 2 to 23 months
First episode of wheezing following the viral infection of the upper respiratory tract
Presence of clinical manifestations of acute bronchiolitis
Absence of consolidation on the chest x-ray
Exclusion criteria:
patients with history of more than one episode of wheezing
history of asthma and allergy in the patients and their family
congenital heart disease
malnutrition
low birth weight
previous antibiotic therapy
pneumonia
intrauterine growth retardation (IUGR)
Age
From 2 months old to 23 months old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who will admitted on odd days will be assigned into intervention group and patients who will admitted on even days will be assigned into control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, participants and researchers are unaware of the type of prescribed drugs for the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardebil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah Avenue
City
Ardabil
Province
Ardabil
Postal code
5163639888
Approval date
2018-10-31, 1397/08/09
Ethics committee reference number
IR.ARUMS.REC.1397.097
Health conditions studied
1
Description of health condition studied
Acute bronchiolitis
ICD-10 code
J21
ICD-10 code description
Acute bronchiolitis
Primary outcomes
1
Description
Tachypnea
Timepoint
Before the intervention; 24 hours, 72 hours and 7 days after the intervention
Method of measurement
Clinical examinations
2
Description
Dyspnea
Timepoint
Before the intervention; 24 hours, 72 hours and 7 days after the intervention
Method of measurement
Clinical examinations
3
Description
Fever
Timepoint
Before the intervention; 24 hours, 72 hours and 7 days after the intervention
Method of measurement
Clinical examinations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: prescribing syrup Zinc gluconate 1%; produced by Simorgh Darou Attar Company, for 5 days; children younger than 1 year of age will receive 10 mg in two divided doses and those over the age of 1 year will receive 20 mg in two divided doses.
Category
Treatment - Drugs
2
Description
Control group: prescribing Placebo; produced by Simorgh Darou Attar Company, for 5 days; children younger than 1 year of age will receive 10 mg in two divided doses and those over the age of 1 year will receive 20 mg in two divided doses.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali hospital
Full name of responsible person
Maryam Rihaniyan
Street address
Boali hospital, Daneshgah Avenue
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2000
Email
Naghizadeh73@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Manochehr Barak
Street address
Boali hospital, Daneshgah Avenue
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2006
Email
Naghizadeh73@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr Adel Ahadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Boali hospital, Daneshgah Avenue
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2000
Email
Naghizadeh73@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Manochehr Barak
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Boali hospital, Daneshgah Avenue
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2006
Email
M.barak@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Maryam Rihaniyan
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Boali hospital, Daneshgah Avenue
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2006
Email
Naghizadeh73@yahoo.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
Total potential data after making individuals data unidentifiable
When the data will become available and for how long
Start the access period from 2021
To whom data/document is available
Researchers at academic and scientific institutions
Under which criteria data/document could be used
Data can be used for scientific and research studies.
From where data/document is obtainable
Maryam Rihaniyan; Medical student; Naghizadeh73@yahoo.com
What processes are involved for a request to access data/document
After receiving the request email, data files will be sent in less than a week.