Trial Outcomes & Findings for Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia (NCT NCT01048502)
NCT ID: NCT01048502
Last Updated: 2016-02-19
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
randomization and 8 weeks post
Results posted on
2016-02-19
Participant Flow
100 subjects were enrolled; 80 completed the study.
Participant milestones
| Measure |
Fenofibrate (Tricor) (145 mg/Day)
Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.
Fenofibrate (Tricor) tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks
|
Placebo
Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.
Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks
|
Lovaza (900 mg/Day)
Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
|
Lovaza (3,600 mg/Day)
Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
28
|
25
|
|
Overall Study
COMPLETED
|
20
|
16
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
5
|
4
|
Reasons for withdrawal
| Measure |
Fenofibrate (Tricor) (145 mg/Day)
Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.
Fenofibrate (Tricor) tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks
|
Placebo
Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.
Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks
|
Lovaza (900 mg/Day)
Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
|
Lovaza (3,600 mg/Day)
Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
5
|
3
|
|
Overall Study
Physician Decision
|
0
|
3
|
0
|
1
|
Baseline Characteristics
Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia
Baseline characteristics by cohort
| Measure |
Fenofibrate (Tricor) (145 mg/Day)
n=24 Participants
Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.
Fenofibrate (Tricor)tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks
|
Placebo
n=23 Participants
Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.
Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks
|
Lovaza (900 mg/Day)
n=28 Participants
Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
|
Lovaza (3,600 mg/Day)
n=25 Participants
Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25.58 years
n=5 Participants
|
25.96 years
n=7 Participants
|
26.68 years
n=5 Participants
|
24.68 years
n=4 Participants
|
25.75 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: randomization and 8 weeks postOutcome measures
| Measure |
Placebo
n=16 Participants
Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.
Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks
|
Lovaza (900 mg/Day)
n=23 Participants
Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
|
Lovaza (3,600 mg/Day)
n=21 Participants
Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
|
|---|---|---|---|
|
The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS).
TNF-α at randomization
|
0.95 pg/mL
Interval 0.8 to 1.68
|
1.26 pg/mL
Interval 0.72 to 1.76
|
1.14 pg/mL
Interval 0.76 to 1.81
|
|
The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS).
TNF-α 8 weeks post randomization
|
1.12 pg/mL
Interval 0.64 to 1.84
|
1.25 pg/mL
Interval 0.78 to 1.76
|
0.99 pg/mL
Interval 0.64 to 1.34
|
SECONDARY outcome
Timeframe: baseline and 6-8 weeksOutcome measures
| Measure |
Placebo
n=20 Participants
Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.
Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks
|
Lovaza (900 mg/Day)
n=16 Participants
Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
|
Lovaza (3,600 mg/Day)
Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
|
|---|---|---|---|
|
Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo.
TNF-α at randomization
|
1.2 pg/mL
Standard Deviation 0.5
|
1.5 pg/mL
Standard Deviation 1.2
|
—
|
|
Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo.
TNF-α 6-8 weeks post randomization
|
1.1 pg/mL
Standard Deviation 0.4
|
0.2 pg/mL
Standard Deviation 1.1
|
—
|
Adverse Events
Tricor (145 mg/Day)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lovaza (900 mg/Day)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Lovaza (3,600 mg/Day)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tricor (145 mg/Day)
n=24 participants at risk
Participants will be given 1 Tricor 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.
Fenofibrate tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks
|
Placebo
n=23 participants at risk
Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.
Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks
|
Lovaza (900 mg/Day)
n=28 participants at risk
Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
|
Lovaza (3,600 mg/Day)
n=25 participants at risk
Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.
Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
> 2g drop in Hgb from baseline
|
4.2%
1/24 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
14.3%
4/28 • Number of events 4
|
4.0%
1/25 • Number of events 1
|
|
General disorders
cold/allergy symptoms
|
12.5%
3/24 • Number of events 3
|
8.7%
2/23 • Number of events 2
|
14.3%
4/28 • Number of events 4
|
28.0%
7/25 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place