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NCT Number: NCT07393399

Omega-3 Supplementation in Systemic Lupus Erythematosus

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Inflammatory markers

    Time frame: Baseline and 12 weeks

    Change in serum inflammatory markers, including interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP), assessed using standard laboratory methods.

  2. Oxidative stress markers

    Time frame: Baseline and 12 weeks

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

  3. Lipid profile

    Time frame: Baseline and 12 weeks

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

  4. Fatty acid profiles

    Time frame: Baseline and 12 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Carolina Nicoletti Ferreira

CONTACT

[email protected]

+5516991293056

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Omega-3 Supplementation in Women With Systemic Lupus Erythematosus: Protocol for a Randomized, Double-blind, Placebo-controlled Trial

Acronym: SLE-OMEGA

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Feb 6, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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