Systemic Lupus ErythematosusNCT01956188
Omega 3 in LES and APS
A study testing EPA and DHA supplementation in people with Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
It has been demonstrated that EPA and DHA supplementation may have anti-inflammatory properties in several chronic diseases, namely, diabetes, obesity, and in rheumatoid arthritis, although not with controversy. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus, Primary Antiphospholipid Syndrome
- What is being tested?
- EPA and DHA supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Dec 2017
- Phase
- Interventional
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 7 and 40 years
Who cannot join
- Cardiovascular dysfunction
- Rhythm and conduction disorders
- Musculoskeletal disturbances
- Kidney and pulmonary involvements
- Peripheral neuropathy
- Use of tobacco
Show all 10Show fewer
- Treatment with lipid-lowering or hypoglycemic drugs
- Fibromyalgia
- Use of chronotropic or antihypertensive drugs
- Physically active subjects
Trial locations and contacts
1 site in 1 country.
Brazil1 site
General Hospital - University of Sao Paulo
São Paulo, São Paulo, 05.403-010
About this study
Official title: Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome
It has been demonstrated that EPA and DHA supplementation may have anti-inflammatory properties in several chronic diseases, namely, diabetes, obesity, and in rheumatoid arthritis, although not with controversy. Systemic lupus erythematosus (SLE) and Antiphospholipid Antibody Syndrome (AAS) are autoimmune diseases characterized by a chronic inflammatory state which is associated with the disease´s clinical symptoms. Thus, we hypothesized that EPA and DHA supplementation may beneficially affect the inflammatory cytokine profile and clinical features of LES and AAS patients.
- Being tested
- EPA and DHA supplementation, Placebo
- 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.
EPA and DHA supplementationDietary supplement
Subjects will be given 3g/d (1,2g of DHA and 1,8g of EPA) - 5 capsules per day.
PlaceboDietary supplement
Subjects will be given 3g/d of soy oil - 5 capsules per day.
| Study group | Role | What they receive |
|---|---|---|
| EPA and DHA supplementation | Experimental | EPA (1800mg/d) and DHA (1200mg/d) supplementation Receives: Dietary Supplement: EPA and DHA supplementation |
| Placebo | Placebo comparator | Soy oil (3000 mg/d) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine profile (serum levels of IL-1B, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-alpha, IFN-y)
Cytokines´ serum levels (pg/ml) will be assessed by Elisa kits.
Measured: 4 months
Endothelial function
Endothelial function assessed by flow mediated dilatation (FMD).
Measured: 4 months
Secondary outcomes (4)
Clical features
Disease activity - assessed by SLEDAI score
Measured: 4 months
Clinical features
Quality of life - assessed by SF-36 questionaire
Measured: 4 months
Clinical features
Fatigue - assessed by 2 questionaires - Chalders´Fatigue Scale and Fatigue Severity Scale (FSS)
Measured: 4 months
Clinical features
Body composition - lean (Kg) and fat mass (Kg) assessed by air displacement pletysmography (BOD POD).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionJul 2017
- Study completionDec 2017 (estimated)
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.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabiana Braga Benatti, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956188
- Sponsor's protocol ID
- Omega 3 and SLE and APS USP
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2013
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Felau SM, Sales LP, Solis MY, Hayashi AP, Roschel H, Sa-Pinto AL, Andrade DCO, Katayama KY, Irigoyen MC, Consolim-Colombo F, Bonfa E, Gualano B, Benatti FB. Omega-3 Fatty Acid Supplementation Improves Endothelial Function in Primary Antiphospholipid Syndrome: A Small-Scale Randomized Double-Blind Placebo-Controlled Trial. Front Immunol. 2018 Mar 2;9:336. doi: 10.3389/fimmu.2018.00336. eCollection 2018.
PubMed 29552010
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome
- ClinicalTrials.gov ID
- NCT01956188
- Acronym / sponsor ID
- Omega 3 and SLE and APS USP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Oct 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.
It has been demonstrated that EPA and DHA supplementation may have anti-inflammatory properties in several chronic diseases, namely, diabetes, obesity, and in rheumatoid arthritis, although not with controversy. Systemic lupus erythematosus (SLE) and Antiphospholipid Antibody Syndrome (AAS) are autoimmune diseases characterized by a chronic inflammatory state which is associated with the disease´s clinical symptoms. Thus, we hypothesized that EPA and DHA supplementation may beneficially affect the inflammatory cytokine profile and clinical features of LES and AAS patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPA and DHA supplementation | Experimental | Dietary Supplement: EPA and DHA supplementationEPA (1800mg/d) and DHA (1200mg/d) supplementation |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSoy oil (3000 mg/d) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 7 and 40 years
Key exclusion criteria (10 listed)
- Cardiovascular dysfunction
- Rhythm and conduction disorders
- Musculoskeletal disturbances
- Kidney and pulmonary involvements
- Peripheral neuropathy
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 |
|---|---|---|
| EPA and DHA supplementationSubjects will be given 3g/d (1,2g of DHA and 1,8g of EPA) - 5 capsules per day. | Dietary supplement | EPA and DHA supplementation |
| PlaceboSubjects will be given 3g/d of soy oil - 5 capsules per day. | Dietary supplement | Placebo |
Primary outcome
Cytokine profile (serum levels of IL-1B, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-alpha, IFN-y)
Time frame: 4 months
Cytokines´ serum levels (pg/ml) will be assessed by Elisa kits.
Endothelial function
Time frame: 4 months
Endothelial function assessed by flow mediated dilatation (FMD).
4 secondary outcomes
Clical features
Time frame: 4 months
Clinical features
Time frame: 4 months
Clinical features
Time frame: 4 months
Clinical features
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
- Derived from this study: PubMed 29552010Felau SM, Sales LP, Solis MY, Hayashi AP, Roschel H, Sa-Pinto AL, Andrade DCO, Katayama KY, Irigoyen MC, Consolim-Colombo F, Bonfa E, Gualano B, Benatti FB. Omega-3 Fatty Acid Supplementation Improves Endothelial Function in Primary Antiphospholipid Syndrome: A Small-Scale Randomized Double-Blind Placebo-Controlled Trial. Front Immunol. 2018 Mar 2;9:336. doi: 10.3389/fimmu.2018.00336. eCollection 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPA and DHA supplementation in people with Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 27 Sep 2017. 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 Brazil. 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.
Are results available for this study?
Results are not available in the source record.
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?
Cytokine profile (serum levels of IL-1B, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-alpha, IFN-y) (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT01956188, 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 Sep 2017.