Trial · NCT01078909
Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation
NCT01078909, Phase 3, Completed, Penn State University; results first posted 2017-06-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation. Trials, record NCT01078909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01078909
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation
- NCT number
- NCT01078909
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 125 participants, actual
- Lead sponsor
- Penn State University
- Conditions
- Cardiovascular Disease, Inflammation
- Interventions
- Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)
- First posted
- 2010-03-02
- Last updated
- 2023-08-21
- Results first posted
- 2017-06-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | 5 months | |
| Primary | Mean Concentrations of CRP Following 5 Months of Treatment | 5 months | |
| Secondary | Change in Lipid Mediators | 1, 2, 3 and 5 days post LPS administration | 0 Participants Analyzed; Lipid mediators were unable to be detected therefore there are no data to report. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | 5 months | One individual was removed from the analysis due to having very high RBC EPA+DHA content at study entry (\>8%) | pg/mL | MEAN |
| PRIMARY | Mean Concentrations of CRP Following 5 Months of Treatment | 5 months | One individual was removed from the analysis due to having very high RBC EPA+DHA content at study entry (\>8%) | mg/dL | MEAN |
| SECONDARY | Change in Lipid Mediators | 1, 2, 3 and 5 days post LPS administration | Lipid mediators were unable to be detected; Data were not collected. |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | 300mg Fish Oil (EPA + DHA) Supplement | TNF-alpha (pg/mL) | 1.4 | 95% Confidence Interval 1.3 to 1.5 | pg/mL |
| Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | 600mg Fish Oil (EPA+DHA) Supplement | TNF-alpha (pg/mL) | 1.3 | 95% Confidence Interval 1.1 to 1.5 | pg/mL |
| Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | 900mg Fish Oil (EPA + DHA) Supplement | TNF-alpha (pg/mL) | 1.4 | 95% Confidence Interval 1.2 to 1.5 | pg/mL |
| Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | 1800mg Fish Oil (EPA + DHA) Supplement | TNF-alpha (pg/mL) | 1.5 | 95% Confidence Interval 1.2 to 1.6 | pg/mL |
| Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | Placebo | TNF-alpha (pg/mL) | 1.4 | 95% Confidence Interval 1.1 to 1.6 | pg/mL |
| Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | 300mg Fish Oil (EPA + DHA) Supplement | IL-6 (pg/mL) | 0.9 | 95% Confidence Interval 0.7 to 1.1 | pg/mL |
| Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | 600mg Fish Oil (EPA+DHA) Supplement | IL-6 (pg/mL) | 1 | 95% Confidence Interval 0.8 to 1.2 | pg/mL |
| Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | 900mg Fish Oil (EPA + DHA) Supplement | IL-6 (pg/mL) | 0.9 | 95% Confidence Interval 0.7 to 1.1 | pg/mL |
| Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | 1800mg Fish Oil (EPA + DHA) Supplement | IL-6 (pg/mL) | 1 | 95% Confidence Interval 0.8 to 1.2 | pg/mL |
| Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment | Placebo | IL-6 (pg/mL) | 0.9 | 95% Confidence Interval 0.7 to 1.1 | pg/mL |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 300mg Fish Oil (EPA + DHA) Supplement | 25 | |
| Overall Study | STARTED | 600mg Fish Oil (EPA+DHA) Supplement | 25 | |
| Overall Study | STARTED | 900mg Fish Oil (EPA + DHA) Supplement | 25 | |
| Overall Study | STARTED | 1800mg Fish Oil (EPA + DHA) Supplement | 25 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | COMPLETED | 300mg Fish Oil (EPA + DHA) Supplement | 23 | |
| Overall Study | COMPLETED | 600mg Fish Oil (EPA+DHA) Supplement | 21 | |
| Overall Study | COMPLETED | 900mg Fish Oil (EPA + DHA) Supplement | 24 | |
| Overall Study | COMPLETED | 1800mg Fish Oil (EPA + DHA) Supplement | 24 | |
| Overall Study | COMPLETED | Placebo | 23 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 300 mg/d EPA + DHA (Fish Oil) Supplement | ||
| Total, all-cause mortality | 600 mg/d EPA + DHA (Fish Oil) Supplement | ||
| Total, all-cause mortality | 900 mg/d EPA + DHA (Fish Oil) Supplement | ||
| Total, all-cause mortality | 1800 mg/d EPA + DHA (Fish Oil) Supplement | ||
| Total, all-cause mortality | 0 mg/d EPA + DHA (Placebo) | ||
| Total, other adverse events | 300 mg/d EPA + DHA (Fish Oil) Supplement | 0 | 23 |
| Total, other adverse events | 600 mg/d EPA + DHA (Fish Oil) Supplement | 0 | 21 |
| Total, other adverse events | 900 mg/d EPA + DHA (Fish Oil) Supplement | 0 | 24 |
| Total, other adverse events | 1800 mg/d EPA + DHA (Fish Oil) Supplement | 0 | 24 |
| Total, other adverse events | 0 mg/d EPA + DHA (Placebo) | 0 | 23 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24252845 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
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/NCT01078909
GET https://conductscience.org/api/trials/v1/NCT01078909/registered