This is a randomized, double blind, placebo-control trial study in 300 children with asthma. We use placebo (sugar) in control group and Zinc Sulfate (50 mg/daily) in intervention group for 8 weeks. All of them have FEV1 less than 80% (moderate Asthma). We do Spirometry before and after treatment. Also we check CBC with Diff for Eosinophilia and total IgE. At Least, we evaluate Effect of Zinc Sulfate on the Spirometry and Clinical Manifestation. Inclusion Criteria: Age Between 5-17 years old, Asthma more than 1 Year, FEV1 <80%. Exclusion criteria: heart, kidney, liver and thyroid diseases; normal Spirometry; recent pneumonia and sinusitis; intake of Vitamins or Trace elements.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105316660N1
Registration date:2011-07-20, 1390/04/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-20, 1390/04/29
Registrant information
Name
Javad Ghafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 0054
Email address
ghafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Zinc Supplement on the Clinical Symptoms and Spirometry in Children with Moderate Asthmatic Disease
Public title
Effect of Zinc Supplement on Children with Asthmatic Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 5-17 years old; asthma more than 1 year; FEV1 <80%.
Exclusion criteria: heart, kidney, liver and thyroid diseases; normal spirometry; recent pneumonia and sinusitis; intake of Vitamins or Trace elements.
Age
From 5 years old to 17 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
300
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
Mazandaran University of Medical Sciences
Street address
Moallem Square
City
Sari
Postal code
Approval date
2010-11-24, 1389/09/03
Ethics committee reference number
89-104
Health conditions studied
1
Description of health condition studied
Asthmatic Patients
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
clinical manifestation of asthma
Timepoint
8 weeks
Method of measurement
observation
2
Description
Spirometry
Timepoint
8 Weeks
Method of measurement
Spirometer
Secondary outcomes
1
Description
Eosinophil
Timepoint
8 weeks
Method of measurement
laboratory test
2
Description
Total IgE
Timepoint
8 Weeks
Method of measurement
Labratory Test
Intervention groups
1
Description
Zinc Sulfte (50 mg/Daily)
Category
Treatment - Drugs
2
Description
Placebo (Suger) for 8 Weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Toba Clinic of Sari
Full name of responsible person
Dr Javad Ghafari
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayati
Street address
No.2 Biulding, Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Javad Ghafari
Position
Alergist and Clinical Immunologist, Associate Professor
Other areas of specialty/work
Street address
Boali Hospital, Pasdaran Blv, Emam Square
City
Sari
Postal code
Phone
+98 15 1223 3011
Fax
Email
javadneg@yahoo.com , ghafari@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Javad Ghafari
Position
Allergist and Clinical Immunologist/ Associate Professor
Other areas of specialty/work
Street address
Boali Hospital, Pasdaran Blv, Emam Square
City
Sari
Postal code
Phone
+98 15 1223 3011
Fax
+98 15122345067
Email
javadneg@yahoo.com , ghafari@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Javad Ghafari
Position
Other areas of specialty/work
Street address
City
Sari
Postal code
Phone
+98 15132612458
Fax
+98 15 1326 1244
Email
javadneg@yahoo.com , ghafari@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)