Objective: The effect of fish oil on the tuberculin skin test in healthy volunteers
Study design: clinical trial, single-blinded, controlled without placebo. Study population
Main inclusion criteria: all medicine, nursing, midwifery students of Qazvin University of Medical Sciences in 2013 and 2014
Main exclusion criteria: known allergy to PPD, immunodeficiency, immunosuppressive drugs such as corticosteroids
Sample size: 175 volunteers. Intervention: students were randomly assigned to two groups receiving fish oil and control. All participants will be tested with 0.1 ml PPD (baseline and after 1 week). The fish oil capsules (daily) for 5 days will be used for first group. intervention time: 2013 and 2014. primary outcome: the maximum transverse diameter of induration after PPD test
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040620882N2
Registration date:2015-05-24, 1394/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-24, 1394/03/03
Registrant information
Name
Abbas Allami
Name of organization / entity
Qazvin University of Medical Scince
Country
Iran (Islamic Republic of)
Phone
+98 28 3337 9630
Email address
allami@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2013-08-22, 1392/05/31
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Fish-oil fatty acid Supplementation on Tuberculin skin test in young healthy volunteers
Public title
Effect of Fish-oil fatty acid Supplementation on immune function
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: medical, nursing and obstetrics students of Qazvin University of Medical Sciences, 18-46 years old
Exclusion criteria: healthy human volunteer
Age
From 18 years old to 46 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
175
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Research Ethics Committee of the Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Blvd. , Qazvin, Iran
City
Qazvin
Postal code
Approval date
2015-03-08, 1393/12/17
Ethics committee reference number
9839/20/28
Health conditions studied
1
Description of health condition studied
Immune response to tuberculin test
ICD-10 code
A16.7
ICD-10 code description
Primary respiratory tuberculosis without mention of bacteriological or histological confirmation
Primary outcomes
1
Description
Tuberculin test induration size
Timepoint
on the second and ninth days
Method of measurement
With a ruler
Secondary outcomes
empty
Intervention groups
1
Description
group receiving fish oil: fish oil gel capsules daily containing 180 mg of eicosapentaenoic (EPA) and 120 mg docosahexaenoic (DHA) for 5 days
Category
Treatment - Drugs
2
Description
Controls: No action
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Abbas Allami
Street address
College of medicine, Qazvin University of Medical Sciences, Bahonar Blvd. , Qazvin, Iran
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mehrnaz Abbasi
Street address
College of medicine, Qazvin University of Medical Sciences, Bahonar Blvd. , Qazvin, Iran
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr Abbas Allami
Position
Associated professor
Other areas of specialty/work
Street address
College of medicine, Qazvin University of Medical Sciences, Bahonar Blvd. , Qazvin, Iran
City
Qazvin
Postal code
8897632
Phone
+98 28 3333 6001
Fax
Email
allami9@yahoo.com, allami@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Abbas Allami
Position
Associated professor
Other areas of specialty/work
Street address
College of medicine, Qazvin University of Medical Sciences, Bahonar Blvd. , Qazvin, Iran
City
Qazvin
Postal code
8897632
Phone
+98 28 3333 6001
Fax
Email
allami9@yahoo.com, allami@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Abbas Allami
Position
Associated professor
Other areas of specialty/work
Street address
College of medicine, Qazvin University of Medical Sciences, Bahonar Blvd. , Qazvin, Iran
City
Qazvin
Postal code
8897632
Phone
+98 28 3333 6001
Fax
Email
allami9@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)