Omega 3 Fatty Acids and Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      Omega-3 fatty acids have been considered anti-inflammatory lipids based on data from
      epidemiological studies of Greenland Eskimos whose diet is rich in fish, sources of
      polyunsaturated fatty acids.

      Fatty acids from the omega-3 family [mainly the α-linolenic acid, eicosapentaenoic (EPA) and
      docosahexaenoic (DHA)], as well as those of the omega-6 family [represented mainly by
      linoleic acid and arachidonic acid (AA)] are essential for the synthesis of eicosanoids,
      prostaglandins, leukotrienes, thromboxanes and other oxidative factors, major mediators and
      regulators of inflammation.

      Systemic lupus erythematosus (SLE) is an inflammatory autoimmune disease characterized by the
      loss of balance of cellular immunoregulation and increased levels of circulating inflammatory
      mediators.Thus, omega-3 supplementation could represent additional therapy for individuals
      with SLE.

      The aim of this study was to investigate the effects of omega-3 fatty acids on circulating
      levels of inflammatory and biochemical markers in women with SLE.
    

Detailed description: 
      This is a pilot clinical trial of omega-3-polyunsaturated fatty acids carried out in SLE
      patients followed at the Rheumatology Unit of Hospital das Clínicas, Universidade Federal de
      Minas Gerais, UFMG.

      Female patients who met the revised American College of Rheumatology (ACR) classiﬁcation
      criteria for SLE (1982/1997)15, age over 18 years old and below 60 years old, who were taking
      stable doses of medications for the SLE treatment in the last three months were included.
      Exclusion criteria were the following: pregnancy, disease duration of less than one year,
      allergy to ﬁsh, ﬁsh oil or any omega-3 product, omega-3 use within the previous six months
      and diagnosis of diabetes mellitus, liver disease, chronic renal failure, any type of
      infection at enrollment and/or throughout the study.

      A 12 week pilot clinical trial of omega-3 fatty acid supplementation was conducted.
      Participants were seen at baseline (T0) and at week 12 (T1) for clinical, laboratory and
      nutritional assessment. Participants were also contacted by telephone in week 6 to check on
      compliance and any adverse events. The patients were randomized into one of two groups in a
      1:1 ratio. Patients in the study group received, throughout 12 weeks, two tablets per day of
      omega-3 fatty acids (540mg of EPA and DHA of 100mg; Hiomega-3 supplement of Naturalis®
      company - registered in the National Health Department number 4.1480.0006.001-4). Patients in
      the control group did not receive the nutrient nor any kind of placebo. All participants were
      instructed not to take omega-3 rich foods during the study period. The researcher (FMMS) who
      did clinical assessment and the inflammatory and biochemical data assessment was blind to
      randomization and intervention.

      Variables measured at each visit included: disease activity index, using the Systemic Lupus
      Disease Activity Index (SLEDAI-2k)16; damage index (Systemic Lupus International
      Collaboration Clinics/American College of Rheumatology damage index - SLICC/ACR)17; fasting
      lipid and glucose proﬁle; standard laboratory tests to assess SLE (red and white blood count,
      platelet count, creatinine, urinalysis, urine protein/creatinine ratio, anti-dsDNA,
      anticardiolipin, C3 and C4 levels); cytokines (IL-6, IL-10), adipokines (leptin, adiponectin)
      C-reactive protein (CRP), nutritional assessment, and in use medications.
    

Intervention name(s): Hiomega-3 supplement of Naturalis® company -
Intervention type(s): Dietary Supplement
Intervention description(s): Patients (N=22) were seen at baseline (T0) and at week 12 (T1) for clinical, laboratory and nutritional assessment, and were contacted by telephone in week 6 to check on compliance and any adverse events. Patients received, throughout 12 weeks, two tablets per day of omega-3 fatty acids (540mg of EPA and DHA of 100mg; Hiomega-3 supplement of Naturalis® company - registered in the National Health Department number 4.1480.0006.001-4). All participants were instructed not to take omega-3 rich foods during the study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Omega 3, Cytokines, Adipokines, Systemic lupus erythematosus