The objective of this study is to survey the influence of zinc sulfate on increasing levels of antibody production following pneumococcal vaccination in people older than 65 years. Participants were assigned into following groups. The patients in the intervention group received single dose of pneumococcal vaccine 23 valent (Merck Company, Germany) injected into the deltoid muscle, intramuscularly, as well as Zinc sulfate capsules (Alhavy company, Iran) 200 mg daily, PO for a month. The patients in the control group received single dose of pneumococcal vaccine 23 valent (Merck Company, Germany) injected into the deltoid muscle, intramuscularly, as well as placebo (capsules filled with sugar) for a month. Specific pneumococcal antibody levels were measured before and one month after vaccination by ELISA method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905094479N1
Registration date:2010-11-09, 1389/08/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-09, 1389/08/18
Registrant information
Name
Seyed Mohamad Karimivafa
Name of organization / entity
Kermanshah University Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1726 3527
Email address
drvafa@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2010-06-22, 1389/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of Zinc on the increase Immune responses after Pneumococcal vaccination (Penumovax) in elderly
Public title
Study the effect of Zinc on the increase Immune responses after Pneumococcal vaccination (Penumovax) in elderly
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 65 years of age, no lung infection, full consent to participate in the study, no allergic or any other systemic diseases, Pneumococcal vaccination the past three years
Age
From 65 years old to 120 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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 Medical Sciences, Shahid Beheshti Street
City
Kermanshah
Postal code
6718647657
Approval date
2010-06-15, 1389/03/25
Ethics committee reference number
89026
Health conditions studied
1
Description of health condition studied
Immunity for pneumococal vaccine
ICD-10 code
J13
ICD-10 code description
Pneumonia due to Streptococcus pneumoniae
Primary outcomes
1
Description
Immunity against pneumococcal vaccine
Timepoint
One Month
Method of measurement
ELIZA
Secondary outcomes
1
Description
Edema and Indurations due to vaccine
Timepoint
One Month
Method of measurement
Observation
Intervention groups
1
Description
pneumococcal vaccine 23 valent (Merck Company, Germany) injected into the deltoid muscle, intramuscularly, as well as Zinc sulfate capsules (Alhavy company, Iran) 200 mg daily, PO for a month
Category
Prevention
2
Description
pneumococcal vaccine 23 valent (Merck Company, Germany) injected into the deltoid muscle, intramuscularly, as well as placebo (capsules filled with sugar) for a month
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University Medical Sciences
Full name of responsible person
Sayed Mohamad Karimi Vafa
Street address
Against Sepah Bank, West Motahary Street
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University Medical Sciences
Full name of responsible person
Seyed Mohamad Karimi Vafa
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 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
Sayed Mohamad Karimi Vafa
Position
Resident
Other areas of specialty/work
Street address
Against Sepah Bank, West Motahary Street
City
kermanshah
Postal code
6718647657
Phone
+98 83 1726 3527
Fax
+98 83 1726 3527
Email
drvafa@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
Faizolah Mansoury
Position
Assistant Professor
Other areas of specialty/work
Street address
Infection Ward, Emam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6330
Fax
Email
fmansoury@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
Seyed Mohammad Karimi Vafa
Position
Resident
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1726 3527
Fax
Email
drmkvafa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)