Trial Outcomes & Findings for Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study (NCT NCT03077724)

NCT ID: NCT03077724

Last Updated: 2019-01-09

Results Overview

Change in total number of cigarettes per day from baseline to 4-weeks

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 28 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2019-01-09

Participant Flow

Participant milestones

Measure	Fish Oil 4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA) Fish oil: Fish oil supplementation	Placebo Olive oil supplements Placebos: Olive Oil capsules
Overall Study STARTED	14	14
Overall Study COMPLETED	6	12
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Measure	Fish Oil 4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA) Fish oil: Fish oil supplementation	Placebo Olive oil supplements Placebos: Olive Oil capsules
Overall Study Lost to Follow-up	5	1
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study

Baseline characteristics by cohort

Measure	Fish Oil n=14 Participants 4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA) Fish oil: Fish oil supplementation	Placebo n=14 Participants Olive oil supplements Placebos: Olive Oil capsules	Total n=28 Participants Total of all reporting groups
Age, Continuous	32 years n=5 Participants	31 years n=7 Participants	31 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants
Marital Status Married	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Marital Status Not Married	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Marital Status Separated/Widowed/Divorced	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Participants with both baseline and 4-week complete data on cigarettes smoked per day

Change in total number of cigarettes per day from baseline to 4-weeks

Outcome measures

Measure	Fish Oil n=6 Participants 4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA) Fish oil: Fish oil supplementation	Placebo n=12 Participants Olive oil supplements Placebos: Olive Oil capsules
Change in Cigarettes Per Day From Baseline to 4-weeks	-0.94 Cigarettes smoked per day Interval -1.6 to 0.5	0 Cigarettes smoked per day Interval -1.0 to 0.0

SECONDARY outcome

Timeframe: 4 weeks

Population: Change from baseline at 4-weeks in Fagerstrom scores

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.

Outcome measures

Measure	Fish Oil n=6 Participants 4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA) Fish oil: Fish oil supplementation	Placebo n=12 Participants Olive oil supplements Placebos: Olive Oil capsules
Change in Fagerström Scores From Baseline to 4-weeks	-1 score on a scale Interval -2.0 to 0.0	0 score on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 4 weeks

Population: Subjects with complete baseline and 4-week measures

Point prevalence abstinence at 4 weeks biochemically confirmed by end-expired carbon monoxide

Outcome measures

Measure	Fish Oil n=6 Participants 4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA) Fish oil: Fish oil supplementation	Placebo n=12 Participants Olive oil supplements Placebos: Olive Oil capsules
Point Prevalence Abstinence	0 Participants	1 Participants

Adverse Events

Fish Oil

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebos

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fish Oil n=14 participants at risk 4.2 grams per day of n-3 long chain polyunsaturated fatty acids (LCPUFA) Fish oil: Fish oil supplementation	Placebos n=14 participants at risk Olive oil supplements Placebos: Olive Oil capsules
Nervous system disorders Hospitalization	7.1% 1/14 • Number of events 1 • 1 month	0.00% 0/14 • 1 month

Other adverse events

Adverse event data not reported

Additional Information

Harvey J Murff

Vanderbilt University Medical Center

Phone: 615 936 8319

Email: harvey.j.murff@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place