Objectives: The aim of current study is to evaluate the effects of omega-3 fatty acids supplementation on nicotine dependence, cigarette craving, cigarette use per day, motivation to smoking cessation, urinary cotinine levels and oxidative stress index in cigarette smokers
Design:Randomized, double-blind, placebo-controlled, single-center.
Setting and conduct: 54 subject heavy smokers in Urmia Emam Khomeini hospital will divide randomly into 2 groups, intervention group (receiving daily 5 gram Omega-3 supplements) and control group (daily 5 gram placebo miglyol) for 3 months.
Participants: inclusion criteria are heavy smokers (a smoker who reports consuming 20 cigarettes or more per day); level of dependence above moderate (Fagerström test for nicotine dependence – FTND ≥ 7 points); depression below mild (Depression Anxiety Stress Scale 21 for depression - DASS 21 < 9 points); anxiety below moderate ( DASS 21 < 9 points); stress below moderate ( DASS 21 <18 points); average motivation to quit smoking (Richmond test – RT > 5 points); exclusion criteria including: psychiatric and neurodegenerative disorders; abusive use of alcohol or other substances.
the urinary cotinine, total oxidant status(TOS), total antioxidant capacity (TAC) and oxidative stress index before and after 3 months intervention will compare between two groups. 24-hour dietary recalls will fill for participants.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092929508N5
Registration date:2016-12-28, 1395/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-28, 1395/10/08
Registrant information
Name
Rasoul Zarrin
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9935
Email address
rasoul.zarrin@uqconnect.edu.au
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Urmia University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of omega-3 fatty acids supplementation on cigarette craving, urinary cotinine levels and oxidative stress index in heavy smokers
Public title
Study of the effects of omega-3 fatty acids supplementation on cigarette craving, urinary cotinine levels and oxidative stress index in heavy smokers
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: heavy smokers (a smoker who reports consuming 20 cigarettes or more per day); level of dependence above moderate (Fagerström test for nicotine dependence – FTND ≥ 7 points); depression below mild (Depression Anxiety Stress Scale 21 for depression - DASS 21 < 9 points); anxiety below moderate ( DASS 21 < 9 points); stress below moderate ( DASS 21 <18 points); average motivation to quit smoking (Richmond test – RT > 5 points);
Exclusion criteria:psychiatric and neurodegenerative disorders; abusive use of alcohol or other substances
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
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 Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Ave, Jahad street, Urmia