Lupus Erythematosus, SystemicSLE-OMEGANCT07393399
Omega-3 Supplementation in Systemic Lupus Erythematosus
A study testing Omega-3 Fatty Acids (EPA plus DHA) in people with Lupus Erythematosus, Systemic, run by University of Sao Paulo.
Trial summary
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether oral omega-3 fatty acid supplementation can modulate inflammation, oxidative stress, and telomere maintenance in women with systemic lupus erythematosus (SLE) in remission. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Omega-3 Fatty Acids (EPA plus DHA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18 to 45 years
- Diagnosis of systemic lupus erythematosus (SLE) according to the EULAR/ACR classification criteria
- Remission or low disease activity, defined as SLEDAI-2K ≤ 4
- On stable doses of hydroxychloroquine and/or glucocorticoids (≤10 mg/day of prednisone or equivalent) for at least 8 weeks prior to enrollment
- Ability and willingness to provide written informed consent
- Willingness to maintain usual dietary patterns and physical activity levels throughout the study period
Who cannot join
- Current use of omega-3 fatty acid supplements or use within the previous 3 months
- Pregnancy or lactation
- Presence of severe infection, neoplastic disease, or diabetes mellitus
- Known allergy or intolerance to fish oil or soybean oil
- Any medical condition or circumstance that, in the investigator's opinion, could interfere with study participation or adherence to the protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Omega-3 Supplementation in Women With Systemic Lupus Erythematosus: Protocol for a Randomized, Double-blind, Placebo-controlled Trial
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether oral omega-3 fatty acid supplementation can modulate inflammation, oxidative stress, and telomere maintenance in women with systemic lupus erythematosus (SLE) in remission. Women aged 18-45 years with SLE (SLEDAI-2K ≤ 4) will be allocated to receive either omega-3 (5,400 mg/day of EPA+DHA) or placebo for 12 weeks. A parallel healthy control group will undergo the same intervention scheme. Clinical, biochemical, and molecular assessments including inflammatory cytokines, oxidative stress markers (TBARS, ORAC, T-AOC), and relative telomere length (T/S ratio) will be conducted at baseline and post-intervention. The trial is designed to determine whether omega-3 can attenuate chronic low-grade inflammation and oxidative imbalance, both key drivers of cellular dysfunction and premature immunosenescence in SLE. Omega-3 PUFAs exert anti-inflammatory effects through competition with arachidonic acid for COX/LOX enzymes and by activating GPR120, which inhibits the TAK1-NF-κB-JNK inflammatory cascade. Their antioxidant effects may further reduce reactive oxygen species and support genomic stability. By integrating clinical, biochemical, and molecular outcomes, this study provides a comprehensive evaluation of omega-3 effects on pathways implicated in accelerated cellular aging in autoimmune diseases. The findings are expected to clarify whether omega-3 supplementation represents a safe, low-cost strategy capable of improving inflammatory and oxidative profiles and contributing to telomere preservation in women with SLE, supporting future precision-nutrition approaches in this population.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Omega-3 Fatty Acids (EPA plus DHA), 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.
Omega-3 Fatty Acids (EPA plus DHA)Dietary supplement
Oral omega-3 fatty acid supplementation (EPA+DHA), 5,400 mg/day for 12 weeks.
PlaceboDietary supplement
Inert soybean oil capsules identical in appearance to the active supplement.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Supplementation | Experimental | Not described Receives: Dietary Supplement: Omega-3 Fatty Acids (EPA plus DHA) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomere length
Change in leukocyte telomere length assessed by quantitative polymerase chain reaction (qPCR), expressed as the telomere-to-single copy gene (T/S) ratio.
Measured: Baseline and 12 weeks
Secondary outcomes (4)
Inflammatory markers
Change in serum inflammatory markers, including interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP), assessed using standard laboratory methods.
Measured: Baseline and 12 weeks
Oxidative stress markers
Change in oxidative stress markers, including malondialdehyde (MDA) and total antioxidant capacity (TAC), measured by validated biochemical assays.
Measured: Baseline and 12 weeks
Lipid profile
Change in serum lipid profile, including total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides.
Measured: Baseline and 12 weeks
Fatty acid profiles
Fatty acids will be converted to fatty acid methyl esters (FAME) via transesterification, assessing by gas chromatograph.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393399
- Sponsor's protocol ID
- SLE_Omega3_RCT
- Acronym
- SLE-OMEGA
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Supplementation in Women With Systemic Lupus Erythematosus: Protocol for a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07393399
- Acronym / sponsor ID
- SLE-OMEGA / SLE_Omega3_RCT
- Conditions
- Lupus Erythematosus, Systemic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 6 Feb 2026 (actual)
- 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 randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether oral omega-3 fatty acid supplementation can modulate inflammation, oxidative stress, and telomere maintenance in women with systemic lupus erythematosus (SLE) in remission. Women aged 18-45 years with SLE (SLEDAI-2K ≤ 4) will be allocated to receive either omega-3 (5,400 mg/day of EPA+DHA) or placebo for 12 weeks. A parallel healthy control group will undergo the same intervention scheme. Clinical, biochemical, and molecular assessments including inflammatory cytokines, oxidative stress markers (TBARS, ORAC, T-AOC), and relative telomere length (T/S ratio) will be conducted at baseline and post-intervention. The trial is designed to determine whether omega-3 can attenuate chronic low-grade inflammation and oxidative imbalance, both key drivers of cellular dysfunction and premature immunosenescence in SLE. Omega-3 PUFAs exert anti-inflammatory effects through competition with arachidonic acid for COX/LOX enzymes and by activating GPR120, which inhibits the TAK1-NF-κB-JNK inflammatory cascade. Their antioxidant effects may further reduce reactive oxygen species and support genomic stability. By integrating clinical, biochemical, and molecular outcomes, this study provides a comprehensive evaluation of omega-3 effects on pathways implicated in accelerated cellular aging in autoimmune diseases. The findings are expected to clarify whether omega-3 supplementation represents a safe, low-cost strategy capable of improving inflammatory and oxidative profiles and contributing to telomere preservation in women with SLE, supporting future precision-nutrition approaches in this population.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Supplementation | Experimental | Dietary Supplement: Omega-3 Fatty Acids (EPA plus DHA) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18 to 45 years
- Diagnosis of systemic lupus erythematosus (SLE) according to the EULAR/ACR classification criteria
- Remission or low disease activity, defined as SLEDAI-2K ≤ 4
- On stable doses of hydroxychloroquine and/or glucocorticoids (≤10 mg/day of prednisone or equivalent) for at least 8 weeks prior to enrollment
- Ability and willingness to provide written informed consent
Key exclusion criteria (5 listed)
- Current use of omega-3 fatty acid supplements or use within the previous 3 months
- Pregnancy or lactation
- Presence of severe infection, neoplastic disease, or diabetes mellitus
- Known allergy or intolerance to fish oil or soybean oil
- Any medical condition or circumstance that, in the investigator's opinion, could interfere with study participation or adherence to the protocol
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 |
|---|---|---|
| Omega-3 Fatty Acids (EPA plus DHA)Oral omega-3 fatty acid supplementation (EPA+DHA), 5,400 mg/day for 12 weeks. | Dietary supplement | Omega-3 Supplementation |
| PlaceboInert soybean oil capsules identical in appearance to the active supplement. | Dietary supplement | Placebo |
Primary outcome
Telomere length
Time frame: Baseline and 12 weeks
Change in leukocyte telomere length assessed by quantitative polymerase chain reaction (qPCR), expressed as the telomere-to-single copy gene (T/S) ratio.
4 secondary outcomes
Inflammatory markers
Time frame: Baseline and 12 weeks
Oxidative stress markers
Time frame: Baseline and 12 weeks
Lipid profile
Time frame: Baseline and 12 weeks
Fatty acid profiles
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acids (EPA plus DHA) in people with Lupus Erythematosus, Systemic, run by University of Sao Paulo.
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 6 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: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Nicoletti Ferreira (+5516991293056, carolnicolettifino@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere length (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.