Omega-3 Supplementation in Systemic Lupus Erythematosus

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Sao Paulo

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Omega-3 Fatty Acids (EPA plus DHA)

    Dietary supplement

    Oral omega-3 fatty acid supplementation (EPA+DHA), 5,400 mg/day for 12 weeks.

  • Placebo

    Dietary supplement

    Inert soybean oil capsules identical in appearance to the active supplement.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Omega-3 SupplementationExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 12 weeks

Secondary outcomes

1

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.

Time frame
Baseline and 12 weeks
2

Oxidative stress markers

Change in oxidative stress markers, including malondialdehyde (MDA) and total antioxidant capacity (TAC), measured by validated biochemical assays.

Time frame
Baseline and 12 weeks
3

Lipid profile

Change in serum lipid profile, including total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides.

Time frame
Baseline and 12 weeks
4

Fatty acid profiles

Fatty acids will be converted to fatty acid methyl esters (FAME) via transesterification, assessing by gas chromatograph.

Time frame
Baseline and 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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