This randomized clinical trial study was carried out in Hajar hospital of Shahrekord Medical Sciences University.The method of sampling was simple. In this study 124 kids with respiratory infection were enrolled and divided in two groups accidentally .The first group in addition to usuall treatment, received zinc sulfate syrup, and placebo was given to the control group. Finally the result of these two groups were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103025951N1
Registration date:2011-06-17, 1390/03/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-17, 1390/03/27
Registrant information
Name
Roya Habibian
Name of organization / entity
Shahrekord University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
r_habibian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shahrekord University of Medical Sciences and Health Services
Expected recruitment start date
2009-03-20, 1387/12/30
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Zinc sulfate effect on children with respiratory infection
Public title
Zinc effect on respiratory infections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children with respiratory infection admited to the pediatric ward of Hajar hospital. Eexclusion criteria: presence of Cyctic Fibrosis; immunodeficiency; malignancy; immunosupresive drug consumption; sickle cell disease; protein malnutrition and if consent was refused.
Age
From 1 year old to 108 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comette of Shahrekord University of Medical Science and Health Services
Street address
Ayatolah kashni Str, Shahrekord University of Medical Science and Health Services
City
Shahrekord
Postal code
8816733418
Approval date
2010-05-25, 1389/03/04
Ethics committee reference number
2-3-89
Health conditions studied
1
Description of health condition studied
pneumonia
ICD-10 code
Jo9-J18
ICD-10 code description
Influenza and pneumonia
2
Description of health condition studied
acute bronchitis
ICD-10 code
J20-J22
ICD-10 code description
Other acute lower respiratory infections
3
Description of health condition studied
bronchiolitis
ICD-10 code
J20-J22
ICD-10 code description
Other acute lower respiratory infections
4
Description of health condition studied
common cold
ICD-10 code
J00-J06
ICD-10 code description
Acute upper respiratory infections
Primary outcomes
1
Description
hospitalization time
Timepoint
daily
Method of measurement
daily visit
2
Description
fever
Timepoint
every 6 hours
Method of measurement
by termometer
3
Description
cough
Timepoint
daily
Method of measurement
question from parents
Secondary outcomes
1
Description
drug side effects
Timepoint
daily
Method of measurement
daily visit and question
Intervention groups
1
Description
In two group, routine and standard treatment was prescribed . Intervention group received 10cc zinc sulfate syrup bid for 5 days.
Category
Treatment - Drugs
2
Description
In two group, routine and standard treatment was prescribed. Control group received placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Roya Habibian
Street address
Shahrekord Parastar str Hajar hospital
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Science and Health Services
Full name of responsible person
Dr. Mahmood Mobasheri
Street address
Ayatolah Kashani Str, Vice chancellor for research, Shahrekord university of Medical Science and Health Services
City
Shahrekord
Grant name
2-125200
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Science and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Science and Health Services
Full name of responsible person
Roya Habibian
Position
Associated proffessor of Infectious Disease Department
Other areas of specialty/work
Street address
Ayatolah Kashani Str, Shahrekord University of Medical Science and Health Services
City
Shahrekord
Postal code
8816733418
Phone
+98 38 1224 0831
Fax
+98 3813812243517
Email
r_habibian@skums.ac.ir
Web page address
www.skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Science and Health Services
Full name of responsible person
Roya Habibian
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Ayatolah Kashani Str, Shahrekord University of Medical Science and Health Services
City
Shahrekord
Postal code
8816733418
Phone
+98 38 1224 0831
Fax
+98 3813812243517
Email
r_habibian@skums.ac.irroya_habibian@yahoo.com
Web page address
www.skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Science and Health Services
Full name of responsible person
Roya Habibian
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Ayatolah Kashani Str, Shahrekord University of Medical Science and Health Services
City
Shahrekord
Postal code
8816733418
Phone
+98 38 1224 0831
Fax
+98 38 1224 3517
Email
r_habibian@skums.ac.irroya_habibian@yahoo.com
Web page address
www.skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)