The objective of this randomized, double blind clinical trials is to evaluate the effect of zinc on antibody titers of seasonal influenza vaccination in hemodialysis patients. In this study, 128 patients who have antibody titers against H1N1, H3N2, and Inf-B less than 1:40 are randomly assigned into intervention or control group. Trivalent influenza vaccine (VAXIGRIP) will be injected in deltoid muscle for the both groups. The intervention group will receive influenza vaccine and zinc sulfate (50mg/ daily/ for 30 days) while the control group will receive influenza vaccine and placebo (sugar, one capsule /daily /for 30 days). After 30 days, antibody titers will be measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011245243N1
Registration date:2011-01-03, 1389/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-03, 1389/10/13
Registrant information
Name
Shaaban Shirzadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 2322 2773
Email address
drshirzadi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2010-11-21, 1389/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of zinc effect on antibody titers of seasonal infiuenza vaccination in hemodialysis person.
Public title
Evaluation of zinc effect on antibody titers of seasonal infiuenza vaccination in hemodialysis person.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: hemodialysis person, serum antibody less than 1:40, absence of flu-like syndrome
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Street
City
Kermanshah
Postal code
6714415333
Approval date
2010-11-09, 1389/08/18
Ethics committee reference number
پ/7/420/9882
Health conditions studied
1
Description of health condition studied
Influenza
ICD-10 code
J09, J18
ICD-10 code description
Influenza and pneumonia
Primary outcomes
1
Description
Immunity for Influenza Viruses
Timepoint
One month after Vaccination
Method of measurement
With Hemaglutination and Inhibition Method
Secondary outcomes
1
Description
Adverse effect of vaccination
Timepoint
One Month
Method of measurement
Observation
Intervention groups
1
Description
An injection of Trivalent influenza vaccine (VAXIGRIP) in deltoid muscle and zinc sulfate (50 mg/ daily/ for 30 days)
Category
Prevention
2
Description
An injection of Trivalent influenza vaccine (VAXIGRIP) injection in deltoid muscle as well as placebo (sugar, one capsule /daily /for 30 days)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Infection Ward, Emam Reza Hospital
Full name of responsible person
Dr. Shaaban Shirzadi
Street address
Infection Ward, Emam Reza Hospital, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mandana Afsharian
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Street
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?