An interventional study of Hiomega-3 supplement of Naturalis® company - in Systemic Lupus Erythematosus, sponsored by Federal University of Minas Gerais. Completed. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-08-17.
Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Treatment
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.
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 49 is close to the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Federal University of Minas Gerais is the lead sponsor of 150 studies on the registry; 18 are open to participants now.
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Inclusion Criteria: 1-Diagnosis of lupus according to American College of Rheumatology (ACR) classification criteria for SLE (1982/1997)
Exclusion Criteria:
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). Participants were seen at baseline (T0) and at week 12 (T1) for clinical, laboratory and nutritional assessment. 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 ; cytokines (IL-6, IL-10), adipokines (leptin, adiponectin) C-reactive protein (CRP), nutritional assessment, and in use medications.
Dietary Supplement: Hiomega-3 supplement of Naturalis® company -
Patients in the control group did not receive the nutrient nor any kind of placebo. They were seen at baseline (T0) and at week 12 (T1) for clinical, laboratory and nutritional assessment. 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 ; cytokines (IL-6, IL-10), adipokines (leptin, adiponectin) C-reactive protein (CRP), nutritional assessment, and in use medications.
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.
Variations of serum cytokines related to omega 3 treatment
The primary outcomes was median (interquartile range, IQR) variations \[ΔV=pre-Treatment (T0) minus post-treatment (T1) concentrations\] of serum cytokines (IL6 e IL 10) after 12 weeks of treatment between groups.
Time frame: Cytokines measurement on T0 (baseline) and T1 (after 12 weeks)
Variations of serum adipokines related to omega 3 treatment
The primary outcomes was median (interquartile range, IQR) variations \[ΔV=pre-Treatment (T0) minus post-treatment (T1) concentrations\] of serum adipokines (leptin and adiponectin) after 12 weeks of treatment between groups.
Time frame: Adipokines measurement on T0 (baseline) and T1 (after 12 weeks)
Variations of serum C reactive protein related to omega 3 treatment
The primary outcomes was median (interquartile range, IQR) variations \[ΔV=pre-Treatment (T0) minus post-treatment (T1) concentrations\] of serum C reactive protein after 12 weeks of treatment between groups.
Time frame: C reactive protein measurement on T0 (baseline) and T1 (after 12 weeks)
Variations of biochemical markers related to omega 3 treatment
The primary outcomes was median (interquartile range, IQR) variations \[ΔV=pre-Treatment (T0) minus post-treatment (T1) concentrations\] of biochemical markers (glucose and lipidis) after 12 weeks of treatment between groups.
Time frame: Biochemical markers measurement on T0 (baseline) and T1 (after 12 weeks)
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Lupus Erythematosus, Systemic→
Federal University of Minas Gerais