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It has been demonstrated that EPA and DHA supplementation may have anti-inflammatory properties in several chronic diseases, namely, diabetes, obesity, and in rheumatoid arthritis, although not with controversy. Systemic lupus erythematosus (SLE) and Antiphospholipid Antibody Syndrome (AAS) are autoimmune diseases characterized by a chronic inflammatory state which is associated with the disease´s clinical symptoms. Thus, we hypothesized that EPA and DHA supplementation may beneficially affect the inflammatory cytokine profile and clinical features of LES and AAS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPA and DHA supplementation | Experimental | EPA (1800mg/d) and DHA (1200mg/d) supplementation |
|
| Placebo | Placebo Comparator | Soy oil (3000 mg/d) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPA and DHA supplementation | Dietary Supplement | Subjects will be given 3g/d (1,2g of DHA and 1,8g of EPA) - 5 capsules per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine profile (serum levels of IL-1B, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-alpha, IFN-y) | Cytokines´ serum levels (pg/ml) will be assessed by Elisa kits. | 4 months |
| Endothelial function | Endothelial function assessed by flow mediated dilatation (FMD). | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clical features | Disease activity - assessed by SLEDAI score | 4 months |
| Clinical features | Quality of life - assessed by SF-36 questionaire |
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Inclusion Criteria:
• Age between 7 and 40 years
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital - University of Sao Paulo | SĂŁo Paulo | SĂŁo Paulo | 05.403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29552010 | Derived | Felau SM, Sales LP, Solis MY, Hayashi AP, Roschel H, Sa-Pinto AL, Andrade DCO, Katayama KY, Irigoyen MC, Consolim-Colombo F, Bonfa E, Gualano B, Benatti FB. Omega-3 Fatty Acid Supplementation Improves Endothelial Function in Primary Antiphospholipid Syndrome: A Small-Scale Randomized Double-Blind Placebo-Controlled Trial. Front Immunol. 2018 Mar 2;9:336. doi: 10.3389/fimmu.2018.00336. eCollection 2018. |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Placebo | Dietary Supplement | Subjects will be given 3g/d of soy oil - 5 capsules per day. |
|
| 4 months |
| Clinical features | Fatigue - assessed by 2 questionaires - Chalders´Fatigue Scale and Fatigue Severity Scale (FSS) | 4 months |
| Clinical features | Body composition - lean (Kg) and fat mass (Kg) assessed by air displacement pletysmography (BOD POD). | 4 months |