Systemic Lupus ErythematosusPhase 2NCT02021513
Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus
A Phase 2 study testing Fish Oil and Olive Oil in people with Systemic Lupus Erythematosus, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a single blind placebo-controlled pilot study involving Systemic Lupus Erythematosus and lupus nephritis patients. We propose to recruit and consent SLE patients who will be randomized to either receive the study drug, an over the counter fish oil supplement, or a placebo that contains olive oil. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Fish Oil and Olive Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or Female
- All ethnic groups
- Aged 18-64
- Biopsy proven diagnosis of Lupus Nephritis and/or fulfillment of 4 or more American College of Rheumatology criteria for the diagnosis of Systemic Lupus Erythematosus
Who cannot join
- Currently taking, or have taken in the last 2 months, fish oil/omega-3 fatty acid/DHA/EPA
- Allergic to fish oil, shellfish, or other fish products
- Pregnant
- Currently taking the medication: Tositumomab (Bexxar)
- Currently taking anti-coagulant medications (Abciximab, Acenocoumarol, Anisindione, Ardeparin, Argatroban, Bivalirudin, Certoparin, Cilostazol, Clopidogrel, Dalteparin, Danaparoid, Defibrotide, Dermatan Sulfate, Desirudin, Dicumarol, Enoxaparin, Eptifibatide, Fondaparinux, Heparin, Lamifiban, Nadroparin, Phenindione, Phenprocoumon, Reviparin, Sibrafiban, Tinzaparin,Tirofiban, Warfarin, Xemilofiban)
Trial locations and contacts
1 site in 1 country.
About this study
This is a single blind placebo-controlled pilot study involving Systemic Lupus Erythematosus and lupus nephritis patients. We propose to recruit and consent SLE patients who will be randomized to either receive the study drug, an over the counter fish oil supplement, or a placebo that contains olive oil. They will have a baseline metabolomic profile (blood test), nutritional assessment, fatigue severity scale, quality of life assessment, and SELENA-SLEDAI lupus disease activity assessments completed at the time of study medication distribution. Once 6 months of either the study drug or placebo is completed, then pill counts, assessments of experience/adherence (including side-effects, adverse effects, complaints, and un-blinding), and repeat nutritional assessment, fatigue severity scale, SELENA-SLEDAI, and metabolomic profile will be assessed. The study duration for each patient will be 6 months from initiation of the study drug. It is hypothesized that patients receiving the fish oil supplement will have improvement in their metabolomic profile. Additionally it is hypothesized that patients receiving the fish oil supplement will have improvement in disease activity, fatigue, and quality of life assessments.
Read the detailed description
Supplementation with EPA and DHA could potentially reduce the inflammatory state of SLE patients. This study is a single blind placebo-controlled pilot for SLE patients with 25 scheduled to receive omega-3 (EPA 2.25g/DHA 2.25g) daily and 25 scheduled to receive placebo (olive oil), for 6 months. Pre and post supplementation assessments will be made to determine if EPA and DHA levels increase, and if the levels of lipid peroxidation products, other cellular energy intermediates, and inflammatory markers are affected by EPA/DHA. Additionally, lupus disease activity, fatigue, quality of life, and diet will be assessed to determine if these parameters are related to the metabolome in SLE.
- Aim 1:
- To determine if the metabolomic disturbances of lupus patients improve following supplementation with omega-3 fatty acids.
- Aim 2:
- To determine if lupus disease activity, fatigue, and quality of life improve and are related to the metabolomic profile changes.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Fish Oil, Olive Oil
- Keywords
- SLE, Fish Oil, Omega-3
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Also called Omega-3 Fatty Acids, DHA/EPA
Fish Oil (2.25gm EPA and 2.25gm DHA total)
Olive OilDietary supplement
Placebo group
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil | Experimental | Fish Oil (2.25gm EPA and 2.25gm DHA total) Receives: Dietary Supplement: Fish Oil |
| Placebo | Placebo comparator | Olive Oil Receives: Dietary Supplement: Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomic profile
Blood collection by venipuncture for serum assessment of metabolomic profile (fatty acids, markers of oxidative stress, markers of inflammation, markers of energy stores).
Measured: Change from baseline at 6 months
Secondary outcomes (3)
Disease Activity
SELENA-SLEDAI
Measured: Change from baseline at 6 months
SF-36
RAND Short Form 36 Quality of Life Assessment
Measured: Change from baseline at 6 months
FSS
Fatigue Severity Scale
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Gale Arriens, University of Texas Southwestern Medical Center
- Investigators
- Cristina G Arriens, MD, Study chair, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021513
- Sponsor's protocol ID
- EO3SLE
- Status last verified
- Dec 2013
- First submitted
- 13 Dec 2013
- Last updated
- 27 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Arriens C, Hynan LS, Lerman RH, Karp DR, Mohan C. Placebo-controlled randomized clinical trial of fish oil's impact on fatigue, quality of life, and disease activity in Systemic Lupus Erythematosus. Nutr J. 2015 Aug 18;14:82. doi: 10.1186/s12937-015-0068-2.
PubMed 26283629
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT02021513
- Acronym / sponsor ID
- EO3SLE
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, Fish Oil, Omega-3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single blind placebo-controlled pilot study involving Systemic Lupus Erythematosus and lupus nephritis patients. We propose to recruit and consent SLE patients who will be randomized to either receive the study drug, an over the counter fish oil supplement, or a placebo that contains olive oil. They will have a baseline metabolomic profile (blood test), nutritional assessment, fatigue severity scale, quality of life assessment, and SELENA-SLEDAI lupus disease activity assessments completed at the time of study medication distribution. Once 6 months of either the study drug or placebo is completed, then pill counts, assessments of experience/adherence (including side-effects, adverse effects, complaints, and un-blinding), and repeat nutritional assessment, fatigue severity scale, SELENA-SLEDAI, and metabolomic profile will be assessed. The study duration for each patient will be 6 months from initiation of the study drug. It is hypothesized that patients receiving the fish oil supplement will have improvement in their metabolomic profile. Additionally it is hypothesized that patients receiving the fish oil supplement will have improvement in disease activity, fatigue, and quality of life assessments.
Detailed description
Supplementation with EPA and DHA could potentially reduce the inflammatory state of SLE patients. This study is a single blind placebo-controlled pilot for SLE patients with 25 scheduled to receive omega-3 (EPA 2.25g/DHA 2.25g) daily and 25 scheduled to receive placebo (olive oil), for 6 months. Pre and post supplementation assessments will be made to determine if EPA and DHA levels increase, and if the levels of lipid peroxidation products, other cellular energy intermediates, and inflammatory markers are affected by EPA/DHA. Additionally, lupus disease activity, fatigue, quality of life, and diet will be assessed to determine if these parameters are related to the metabolome in SLE.
- Aim 1:
- To determine if the metabolomic disturbances of lupus patients improve following supplementation with omega-3 fatty acids.
- Aim 2:
- To determine if lupus disease activity, fatigue, and quality of life improve and are related to the metabolomic profile changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish Oil | Experimental | Dietary Supplement: Fish OilFish Oil (2.25gm EPA and 2.25gm DHA total) |
| Placebo | Placebo comparator | Dietary Supplement: Olive OilOlive Oil |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or Female
- All ethnic groups
- Aged 18-64
- Biopsy proven diagnosis of Lupus Nephritis and/or fulfillment of 4 or more American College of Rheumatology criteria for the diagnosis of Systemic Lupus Erythematosus
Key exclusion criteria (5 listed)
- Currently taking, or have taken in the last 2 months, fish oil/omega-3 fatty acid/DHA/EPA
- Allergic to fish oil, shellfish, or other fish products
- Pregnant
- Currently taking the medication: Tositumomab (Bexxar)
- Currently taking anti-coagulant medications (Abciximab, Acenocoumarol, Anisindione, Ardeparin, Argatroban, Bivalirudin, Certoparin, Cilostazol, Clopidogrel, Dalteparin, Danaparoid, Defibrotide, Dermatan Sulfate, Desirudin, Dicumarol, Enoxaparin, Eptifibatide, Fondaparinux, Heparin, Lamifiban, Nadroparin, Phenindione, Phenprocoumon, Reviparin, Sibrafiban, Tinzaparin,Tirofiban, Warfarin, Xemilofiban)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish OilAlso: Omega-3 Fatty Acids, DHA/EPAFish Oil (2.25gm EPA and 2.25gm DHA total) | Dietary supplement | Fish Oil |
| Olive OilPlacebo group | Dietary supplement | Placebo |
Primary outcome
Metabolomic profile
Time frame: Change from baseline at 6 months
Blood collection by venipuncture for serum assessment of metabolomic profile (fatty acids, markers of oxidative stress, markers of inflammation, markers of energy stores).
3 secondary outcomes
Disease Activity
Time frame: Change from baseline at 6 months
SF-36
Time frame: Change from baseline at 6 months
FSS
Time frame: Change from baseline at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2013.
- Derived from this study: PubMed 26283629Arriens C, Hynan LS, Lerman RH, Karp DR, Mohan C. Placebo-controlled randomized clinical trial of fish oil's impact on fatigue, quality of life, and disease activity in Systemic Lupus Erythematosus. Nutr J. 2015 Aug 18;14:82. doi: 10.1186/s12937-015-0068-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina G Arriens, MD study chair
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fish Oil and Olive Oil in people with Systemic Lupus Erythematosus, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomic profile (time frame: Change from baseline at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02021513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2013.