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Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study (FORTUNE)

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ClinicalTrials.gov Identifier: NCT03077724
Recruitment Status : Completed
First Posted : March 13, 2017
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Harvey Murff, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Tobacco Use in Childbirth
Smoking Cessation
Pregnancy Related
Interventions Drug: Fish oil
Drug: Placebos
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fish Oil Placebo
Hide Arm/Group Description

4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)

Fish oil: Fish oil supplementation

Olive oil supplements

Placebos: Olive Oil capsules

Period Title: Overall Study
Started 14 14
Completed 6 12
Not Completed 8 2
Reason Not Completed
Lost to Follow-up             5             1
Withdrawal by Subject             3             1
Arm/Group Title Fish Oil Placebo Total
Hide Arm/Group Description

4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)

Fish oil: Fish oil supplementation

Olive oil supplements

Placebos: Olive Oil capsules

Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
32
(25 to 35)
31
(28 to 34)
31
(27 to 35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female 14 14 28
Male 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 1 4 5
White 12 9 21
More than one race 0 0 0
Unknown or Not Reported 1 1 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 14 participants 28 participants
14 14 28
Marital Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Married 5 2 7
Not Married 6 11 17
Separated/Widowed/Divorced 3 1 4
1.Primary Outcome
Title Change in Cigarettes Per Day From Baseline to 4-weeks
Hide Description Change in total number of cigarettes per day from baseline to 4-weeks
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with both baseline and 4-week complete data on cigarettes smoked per day
Arm/Group Title Fish Oil Placebo
Hide Arm/Group Description:

4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)

Fish oil: Fish oil supplementation

Olive oil supplements

Placebos: Olive Oil capsules

Overall Number of Participants Analyzed 6 12
Median (Inter-Quartile Range)
Unit of Measure: Cigarettes smoked per day
-0.94
(-1.6 to 0.5)
0
(-1.0 to 0)
2.Secondary Outcome
Title Change in Fagerström Scores From Baseline to 4-weeks
Hide Description Change in the Fagerström Test for Nicotine Dependency Score from baseline to 4-weeks. This scale is a validated instrument that measures nicotine dependency. The Fagerström Test for Nicotine Dependency is a 6-time survey. Each item is scores with a minimal score of 0 and a maximal score of 10. Higher scores indicate a higher level of nicotine dependency.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Change from baseline at 4-weeks in Fagerstrom scores
Arm/Group Title Fish Oil Placebo
Hide Arm/Group Description:

4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)

Fish oil: Fish oil supplementation

Olive oil supplements

Placebos: Olive Oil capsules

Overall Number of Participants Analyzed 6 12
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
-1
(-2 to 0)
0
(0 to 0)
3.Secondary Outcome
Title Point Prevalence Abstinence
Hide Description Point prevalence abstinence at 4 weeks biochemically confirmed by end-expired carbon monoxide
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with complete baseline and 4-week measures
Arm/Group Title Fish Oil Placebo
Hide Arm/Group Description:

4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)

Fish oil: Fish oil supplementation

Olive oil supplements

Placebos: Olive Oil capsules

Overall Number of Participants Analyzed 6 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   8.3%
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fish Oil Placebos
Hide Arm/Group Description

4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA)

Fish oil: Fish oil supplementation

Olive oil supplements

Placebos: Olive Oil capsules

All-Cause Mortality
Fish Oil Placebos
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Fish Oil Placebos
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      0/14 (0.00%)    
Nervous system disorders     
Hospitalization * [1]  1/14 (7.14%)  1 0/14 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Patient was on suboxone and noted after starting the study that she had lost her suboxone prescription. She presented to the emergency room and was admitted.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fish Oil Placebos
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)    
This was a feasibility study and the overall number of subjects was small. There was significant lost to follow up
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Harvey J Murff
Organization: Vanderbilt University Medical Center
Phone: 615 936 8319
Responsible Party: Harvey Murff, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03077724     History of Changes
Other Study ID Numbers: 161820
First Submitted: March 3, 2017
First Posted: March 13, 2017
Results First Submitted: November 12, 2018
Results First Posted: January 9, 2019
Last Update Posted: January 9, 2019