Protocol summary

Summary
Our goal is to investigate reducing the effects of free radicals on biomolecules such as nucleic acids, proteins, and lipids by using omega-3 in smokers. 80 healthy men (40 smokers and 40 nonsmokers) with age of 25 to 50 years old will receive one gram of omega-3 fatty acid (capsules manufactured by Zahravi Pharmaceutical Company) one hour after a meal everyday for a period of three months. Patients with cardiovascular disorders, metabolic disease such as diabetes, cancer, malabsorption disorders, and renal failure are excluded. A person is considered as smoker if he smokes more than 10 cigarettes in a day for 2 years prior to study. Levels of 8OHdG and OX-LDL will be measured before the study and 3 months after the completion of the treatment period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138803101267N4
Registration date: 2009-08-30, 1388/06/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2009-08-30, 1388/06/08
Registrant information
Name
Mojgan Borgheie
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University of Mediacal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
research@unrc.ir
Recruitment status
Recruitment complete
Funding source
Urology and Nephrology Research Center
Expected recruitment start date
2008-12-21, 1387/10/01
Expected recruitment end date
2010-12-21, 1389/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of omega 3 intake on ‍cancer risk factors in smokers
Public title
Effect of omega 3 intake on ‍cancer risk factors in smokers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: male sex, age between 25 and 50 years old Exclusion criteria: Presence of cardiovascular disorders, metabolic disease such as diabetes, cancer, malabsorption disorders, or renal failure
Age
From 25 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R.
Street address
UNRC, No.101, 9th Boostan St., Pasdaran Ave., Tehran, I.R.Iran
City
Tehran
Postal code
1666677951
Approval date
empty
Ethics committee reference number
93

Health conditions studied

1

Description of health condition studied
Cancer of urinary tract
ICD-10 code
C64, C65,
ICD-10 code description
Malignant neoplasms of urinary tract

Primary outcomes

1

Description
Carbonil level in serum
Timepoint
Baseline and 3 month later
Method of measurement
ELISA

Secondary outcomes

1

Description
OX-LDL level
Timepoint
Baseline and 3 month later
Method of measurement
ELISA

2

Description
8OHdG levels
Timepoint
At first and 3 month later
Method of measurement
ELISA

Intervention groups

1

Description
Omega 3 capsule, 1 gram for 3 month
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.
Full name of responsible person
Shabnam Golshan
Street address
UNRC, No.101, 9th Boostan St., Pasdaran Ave., Tehran, I.R.Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.
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
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.
Full name of responsible person
Dr Hassan Argani
Position
Associate Professor
Other areas of specialty/work
Street address
UNRC, No.101, 9th Boostan St., Pasdaran Ave., Tehran, I.R.Iran
City
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Fax
+98 21 77954
Email
Research@unrc.ir
Web page address
www.unrc.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.
Full name of responsible person
Dr Hassan Argani
Position
Associate Profassor
Other areas of specialty/work
Street address
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R. Iran
City
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Fax
+98 212277954
Email
hassanargani@gmail.com
Web page address
www.unrc.ir

Person responsible for updating data

Contact
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.(SBMU), Tehran, I.R.
Full name of responsible person
Dr Mozhgan Borgheie
Position
General physician
Other areas of specialty/work
Street address
UNRC, No.101,9th Boostan St., Pasdaran Ave., Tehran, I.R.Iran
City
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Fax
+98 212277954
Email
borgheie@unrc.ir
Web page address
www.unrc.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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