Trial Outcomes & Findings for Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries (NCT NCT00935766)

Results Overview

We conducted a prospective, randomized; double-blinded study of omega-3 fatty acids among 60 Latino and White hypertensive patients at risk for CVD. Patients received either 4-g omega-3 fatty acids or matched placebo daily. The principal outcome measure was change in brachial-ankle PWV. .

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

76 participants

Primary outcome timeframe

Baseline, 3 months

Results posted on

2014-09-29

Participant Flow

The study was discontinued early due to lack of funding and slow enrollment

Participant milestones

Participant milestones
Measure	Placebo Placebo (Four 1-gram capsules daily)	Omega 3 omega-3-acid ethyl esters (Four 1-gram capsules daily)
Overall Study STARTED	42	34
Overall Study COMPLETED	35	27
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=35 Participants Placebo (Four 1-gram capsules daily)	Omega 3 n=27 Participants omega-3-acid ethyl esters (Four 1-gram capsules daily)	Total n=62 Participants Total of all reporting groups
Age, Continuous	60.2 years STANDARD_DEVIATION 10.8 • n=5 Participants	62.3 years STANDARD_DEVIATION 9.7 • n=7 Participants	61.1 years STANDARD_DEVIATION 10.3 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	22 Participants n=7 Participants	51 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	27 participants n=7 Participants	62 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

We conducted a prospective, randomized; double-blinded study of omega-3 fatty acids among 60 Latino and White hypertensive patients at risk for CVD. Patients received either 4-g omega-3 fatty acids or matched placebo daily. The principal outcome measure was change in brachial-ankle PWV. .

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Placebo (Four 1-gram capsules daily)	Omega 3 n=27 Participants omega-3-acid ethyl esters (Four 1-gram capsules daily)
Change in Pulse Wave Velocity in Active vs. Placebo-treated Patients.	-33 cm/sec Standard Deviation 306	-97 cm/sec Standard Deviation 182

SECONDARY outcome

Timeframe: baseline, 3 months

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Placebo (Four 1-gram capsules daily)	Omega 3 n=27 Participants omega-3-acid ethyl esters (Four 1-gram capsules daily)
Change in Lipoprotein-associated Phospholipase A2 (LpPLA2)	-6.1 ng/mL Standard Deviation 31.7	-18.1 ng/mL Standard Deviation 41.1

SECONDARY outcome

Timeframe: baseline, 3 months

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Placebo (Four 1-gram capsules daily)	Omega 3 n=27 Participants omega-3-acid ethyl esters (Four 1-gram capsules daily)
Change in hsCRP	0.9 mg/L Standard Deviation 4.4	-0.9 mg/L Standard Deviation 3.1

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omega 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carlin Long, MD

Denver Health Medical Center

Phone: 303-602-3899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI shall furnish copies of any proposed publication or presentation to the Sponsor for review at least thirty (30) days in advance of the submission of such proposed publication or presentation to a journal, editor or other third party. The sponsor shall have thirty (30) days after receipt of said copies, to object to such proposed presentation or proposed publication.
Publication restrictions are in place

Restriction type: OTHER