Trial Outcomes & Findings for Efficacy of Fish Oil in Lupus Patients (NCT NCT00828178)

Results Overview

The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

106 participants

Primary outcome timeframe

12 weeks

Results posted on

2016-11-18

Participant Flow

106 patients were consented and 87 were randomized. Patients were part of the Hopkins Lupus Cohort seen quarterly.

Some of patients were excluded before being randomized for several reasons including "change of mind by patient, became pregnant, diagnosed with breast ca". Therefore a total of 87 patients started the trial.

Participant milestones

Participant milestones
Measure	Fish Oil fish oil 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters) daily	Placebo Placebo (corn starch) once daily
Overall Study STARTED	42	45
Overall Study COMPLETED	42	43
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Fish Oil in Lupus Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fish Oil n=42 Participants 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)	Placebo n=45 Participants corn starch	Total n=87 Participants Total of all reporting groups
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	42 Participants n=5 Participants	45 Participants n=7 Participants	87 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	48.9 years STANDARD_DEVIATION 10.6 • n=5 Participants	45.5 years STANDARD_DEVIATION 10.8 • n=7 Participants	47.2 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	39 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	45 participants n=7 Participants	87 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Patients who successfully completed the trial.

The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks).

Outcome measures

Outcome measures
Measure	Omega-3 n=42 Participants 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)	Placebo n=43 Participants Corn starch
Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo. Post-treatment baseline diameter	0.32 cm Standard Deviation 0.04	0.33 cm Standard Deviation 0.06
Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo. Pre-treatment baseline diameter	0.32 cm Standard Deviation 0.06	0.33 cm Standard Deviation 0.06

SECONDARY outcome

Timeframe: pre-treatment(baseline) and post-treatment (after 12 weeks)

The assessment measured change in disease activities using SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index Selena Modification - range 0-105) and PGA (Physician Global Assessment - range 0-3) comparing pre-treatment(baseline) vs post-treatment (after 12 weeks). SELENA-SLEDAI - range 0-105, high score indicates high disease activity - weighted sum of sub-scale is used as total score. PGA - range 0-3, high score indicates high disease activity.

Outcome measures

Outcome measures
Measure	Omega-3 n=42 Participants 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)	Placebo n=43 Participants Corn starch
Effect of Omega-3 Versus Placebo on Disease Activity in SLE. SELENA-SLEDAI	1.5 Units on a scale Standard Deviation 2	1.5 Units on a scale Standard Deviation 2.5
Effect of Omega-3 Versus Placebo on Disease Activity in SLE. PGA	0.49 Units on a scale Standard Deviation 0.52	0.41 Units on a scale Standard Deviation 0.49

SECONDARY outcome

Timeframe: pre-treatment(baseline) and post-treatment (after 12 weeks)

The inflammatory markers (sICAM-1 and sVCAM-1) were assessed and compared before and after treatment. change from baseline were reported.

Outcome measures

Outcome measures
Measure	Omega-3 n=42 Participants 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)	Placebo n=43 Participants Corn starch
Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo. sICAM-1	-1.61 ng/ml Standard Deviation 40.27	-5.56 ng/ml Standard Deviation 48.74
Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo. sVCAM-1	-17.52 ng/ml Standard Deviation 101.65	26.57 ng/ml Standard Deviation 135.98

Adverse Events

Omega-3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Michelle Petri

Johns Hopkins University School of Medicine

Phone: 410-955-9114

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place