This objective of this randomized, double blind clinical trials is to evaluate the effect of selenium on antibody titers of seasonal infiuenza vaccination in adult older than 4o years. In this study, 116 persons 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 selenium selinate (200 micro/ gm / 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:IRCT201010184959N1
Registration date:2010-11-12, 1389/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-11-12, 1389/08/21
Registrant information
Name
Sohrab Heidari
Name of organization / entity
Kermanshah University Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1426 3264
Email address
a-heidary@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 selenium effect on antibody titers of seasonal infiuenza vaccination in adult older than 40 years in, Imam Reza hospital, Kermanshah
Public title
Evaluation of selenium effect on antibody titers of seasonal infiuenza vaccination in adults older than 40 years
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 40 years old, serum antibody less than 1:40, absence of flu-like syndrome
Age
From 50 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
116
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 Committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Street
City
Kermanshah
Postal code
6714415333
Approval date
2010-09-06, 1389/06/15
Ethics committee reference number
پ/7/420/6212
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 selenium selinate (200 micro gm/ daily/ for 30 days)
Category
Prevention
2
Description
Trivalent influenza vaccine (VAXIGRIP) will be injected in deltoid muscle and placebo daily/ for 30 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Infection Ward, Emam Reza Hospital
Full name of responsible person
Dr. Sohrab Heidari
Street address
Infection Ward, Emam Reza Hospital
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Alireza Janbakhsh
Street address
Infection Ward, Emam Reza Hospital
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sohrab Heidari
Position
Resident
Other areas of specialty/work
Street address
Infection Ward, Emam Reza Hospital
City
Kermanshah
Postal code
67144-15333
Phone
+98 83 1426 3264
Fax
+98 83 1426 3264
Email
www.heidarisohrab@yahoo.com A-Heidary@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Alireza Janbakhsh
Position
Associate professor of Kermanshah University of Medical Sciences
Other areas of specialty/work
Street address
Infection Ward,Emam Reza Hospital
City
Kermanshah
Postal code
67144-15333
Phone
+98 83 1427 6342
Fax
+98 83 1427 6342
Email
a_janbakhsh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sohrab Heidari
Position
Resident
Other areas of specialty/work
Street address
Infection Ward, Emam Reza Hospital
City
Kermanshah
Postal code
6714415333
Phone
+98 83 1426 3264
Fax
+98 83 1426 3264
Email
www.heidarisohrab@yahoo.com A-Heiday@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)