Trial · NCT02939079
Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients
NCT02939079, Phase 2, Phase 3, Completed, Isfahan University of Medical Sciences; results first posted 2019-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients. Trials, record NCT02939079. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02939079
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients
- NCT number
- NCT02939079
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 50 participants, actual
- Lead sponsor
- Isfahan University of Medical Sciences
- Conditions
- Multiple Sclerosis
- Interventions
- Fingolimod, Fish Oil, Placebo (for Fish Oil)
- First posted
- 2016-10-19
- Last updated
- 2019-05-14
- Results first posted
- 2019-05-14
- Limitations and caveats
Small sample size and trial duration; Not giving patients specific nutritional diets; Receiving tocopherol in the placebo capsules which may confound our findings considering the antioxidant nature of tocopherol; Lower doses of fish oil prescribed.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum Level of TNF-α | Baseline | 5 cc of venous blood is taken from patients and are kept in test tubes without ethylenediaminetetraacetic acid (EDTA). Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions. |
| Primary | Serum Level of IL1b | Baseline | 5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions. |
| Primary | Serum Level of IL6 | Baseline | 5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions. |
| Primary | Serum Level of IFN-gamma | Baseline | 5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions. |
| Primary | Serum Level of TNF-α | 6 months after intervention | 5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions. |
| Primary | Serum Level of TNF-α | 1 year after intervention | 5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions. |
| Primary | Serum Level of IL1b | 6 months after intervention | 5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions. |
| Primary | Serum Level of IL1b | 1 year after intervention | 5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions. |
| Primary | Serum Level of IL6 | 6 months after intervention | 5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions. |
| Primary | Serum Level of IL6 | 1 year after intervention | 5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serum Level of TNF-α | Baseline | Per-protocol analysis | Pg/ml | MEAN |
| PRIMARY | Serum Level of IL1b | Baseline | Pg/ml | MEAN | |
| PRIMARY | Serum Level of IL6 | Baseline | Pg/ml | MEAN | |
| PRIMARY | Serum Level of IFN-gamma | Baseline | Pg/ml | MEAN | |
| PRIMARY | Serum Level of TNF-α | 6 months after intervention | Pg/ml | MEAN | |
| PRIMARY | Serum Level of TNF-α | 1 year after intervention | Pg/ml | MEAN | |
| PRIMARY | Serum Level of IL1b | 6 months after intervention | Pg/ml | MEAN | |
| PRIMARY | Serum Level of IL1b | 1 year after intervention | Pg/ml | MEAN | |
| PRIMARY | Serum Level of IL6 | 6 months after intervention | Pg/ml | MEAN | |
| PRIMARY | Serum Level of IL6 | 1 year after intervention | Pg/ml | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serum Level of TNF-α | Fingolimod and Fish Oil | 37.16 | Standard Deviation 92.74 | Pg/ml | |
| Serum Level of TNF-α | Fingolimod and Placebo | 28.79 | Standard Deviation 47.46 | Pg/ml | |
| Serum Level of IL1b | Fingolimod and Fish Oil | 13.76 | Standard Deviation 0.74 | Pg/ml | |
| Serum Level of IL1b | Fingolimod and Placebo | 14 | Standard Deviation 1.03 | Pg/ml | |
| Serum Level of IL6 | Fingolimod and Fish Oil | 6.19 | Standard Deviation 0.35 | Pg/ml | |
| Serum Level of IL6 | Fingolimod and Placebo | 6.33 | Standard Deviation 0.58 | Pg/ml | |
| Serum Level of IFN-gamma | Fingolimod and Fish Oil | 6.38 | Standard Deviation 1.51 | Pg/ml | |
| Serum Level of IFN-gamma | Fingolimod and Placebo | 6.98 | Standard Deviation 3.87 | Pg/ml | |
| Serum Level of TNF-α | Fingolimod and Fish Oil | 28.03 | Standard Deviation 60.36 | Pg/ml | |
| Serum Level of TNF-α | Fingolimod and Placebo | 17.18 | Standard Deviation 18.88 | Pg/ml |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fingolimod and Fish Oil | 25 | |
| Overall Study | STARTED | Fingolimod and Placebo | 25 | |
| Overall Study | COMPLETED | Fingolimod and Fish Oil | 21 | |
| Overall Study | COMPLETED | Fingolimod and Placebo | 20 | |
| Overall Study | NOT COMPLETED | Fingolimod and Fish Oil | 4 | |
| Overall Study | NOT COMPLETED | Fingolimod and Placebo | 5 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Hypotension and bradycardia | Cardiac disorders | Fingolimod and Fish Oil | 2 | 25 | 2 |
| serious | Hypotension and bradycardia | Cardiac disorders | Fingolimod and Placebo | 2 | 25 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fingolimod and Fish Oil | 0 | 25 |
| Total, all-cause mortality | Fingolimod and Placebo | 0 | 25 |
| Total, other adverse events | Fingolimod and Fish Oil | 0 | 25 |
| Total, other adverse events | Fingolimod and Placebo | 0 | 25 |
| Total, serious adverse events | Fingolimod and Fish Oil | 2 | 25 |
| Total, serious adverse events | Fingolimod and Placebo | 2 | 25 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fingolimod and Fish Oil vs Fingolimod and Placebo: deaths from any cause | Trial comparisons |
| Fingolimod and Fish Oil vs Fingolimod and Placebo: serious adverse events | Trial comparisons |
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/NCT02939079
GET https://conductscience.org/api/trials/v1/NCT02939079/results?page=2