Trial · NCT01048502
Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia
NCT01048502, Not applicable, Completed, University of Pennsylvania; results first posted 2016-02-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia. Trials, record NCT01048502. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01048502
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia
- NCT number
- NCT01048502
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 100 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Cardiovascular Disease
- Interventions
- Fenofibrate (Tricor) tablets, Placebo, Lovaza
- First posted
- 2010-01-13
- Last updated
- 2016-02-19
- Results first posted
- 2016-02-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS). | randomization and 8 weeks post | |
| Secondary | Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo. | baseline and 6-8 weeks |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS). | randomization and 8 weeks post | pg/mL | MEDIAN | |
| SECONDARY | Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo. | baseline and 6-8 weeks | pg/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS). | Placebo | TNF-α at randomization | 0.95 | Inter-Quartile Range 0.8 to 1.68 | pg/mL |
| The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS). | Lovaza (900 mg/Day) | TNF-α at randomization | 1.26 | Inter-Quartile Range 0.72 to 1.76 | pg/mL |
| The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS). | Lovaza (3,600 mg/Day) | TNF-α at randomization | 1.14 | Inter-Quartile Range 0.76 to 1.81 | pg/mL |
| The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS). | Placebo | TNF-α 8 weeks post randomization | 1.12 | Inter-Quartile Range 0.64 to 1.84 | pg/mL |
| The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS). | Lovaza (900 mg/Day) | TNF-α 8 weeks post randomization | 1.25 | Inter-Quartile Range 0.78 to 1.76 | pg/mL |
| The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS). | Lovaza (3,600 mg/Day) | TNF-α 8 weeks post randomization | 0.99 | Inter-Quartile Range 0.64 to 1.34 | pg/mL |
| Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo. | Fenofibrate (Tricor) (145 mg/Day) | TNF-α at randomization | 1.2 | Standard Deviation 0.5 | pg/mL |
| Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo. | Placebo | TNF-α at randomization | 1.5 | Standard Deviation 1.2 | pg/mL |
| Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo. | Fenofibrate (Tricor) (145 mg/Day) | TNF-α 6-8 weeks post randomization | 1.1 | Standard Deviation 0.4 | pg/mL |
| Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo. | Placebo | TNF-α 6-8 weeks post randomization | 0.2 | Standard Deviation 1.1 | pg/mL |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fenofibrate (Tricor) (145 mg/Day) | 24 | |
| Overall Study | STARTED | Placebo | 23 | |
| Overall Study | STARTED | Lovaza (900 mg/Day) | 28 | |
| Overall Study | STARTED | Lovaza (3,600 mg/Day) | 25 | |
| Overall Study | COMPLETED | Fenofibrate (Tricor) (145 mg/Day) | 20 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | COMPLETED | Lovaza (900 mg/Day) | 23 | |
| Overall Study | COMPLETED | Lovaza (3,600 mg/Day) | 21 | |
| Overall Study | NOT COMPLETED | Fenofibrate (Tricor) (145 mg/Day) | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | > 2g drop in Hgb from baseline | Blood and lymphatic system disorders | Tricor (145 mg/Day) | 1 | 24 | 1 |
| other | > 2g drop in Hgb from baseline | Blood and lymphatic system disorders | Placebo | 1 | 23 | 1 |
| other | > 2g drop in Hgb from baseline | Blood and lymphatic system disorders | Lovaza (900 mg/Day) | 4 | 28 | 4 |
| other | > 2g drop in Hgb from baseline | Blood and lymphatic system disorders | Lovaza (3,600 mg/Day) | 1 | 25 | 1 |
| other | cold/allergy symptoms | General disorders | Tricor (145 mg/Day) | 3 | 24 | 3 |
| other | cold/allergy symptoms | General disorders | Placebo | 2 | 23 | 2 |
| other | cold/allergy symptoms | General disorders | Lovaza (900 mg/Day) | 4 | 28 | 4 |
| other | cold/allergy symptoms | General disorders | Lovaza (3,600 mg/Day) | 7 | 25 | 7 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tricor (145 mg/Day) | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Lovaza (900 mg/Day) | ||
| Total, all-cause mortality | Lovaza (3,600 mg/Day) | ||
| Total, other adverse events | Tricor (145 mg/Day) | 4 | 24 |
| Total, other adverse events | Placebo | 3 | 23 |
| Total, other adverse events | Lovaza (900 mg/Day) | 8 | 28 |
| Total, other adverse events | Lovaza (3,600 mg/Day) | 8 | 25 |
| Total, serious adverse events | Tricor (145 mg/Day) | 0 | 24 |
| Total, serious adverse events | Placebo | 0 | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50HL083799 | Lipids as Modulators of the Response to Vascular Injury | FITZGERALD, GARRET A | UNIVERSITY OF PENNSYLVANIA | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01048502
GET https://conductscience.org/api/trials/v1/NCT01048502/registered