Omega 3 in LES and APS

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome

Conditions
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Systemic Lupus Erythematosus, Primary Antiphospholipid Syndrome

Intervention / Treatment
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* Dietary Supplement: EPA and DHA supplementation
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Age between 7 and 40 years Exclusion Criteria: Cardiovascular dysfunction Rhythm and conduction disorders Musculoskeletal disturbances Kidney and pulmonary involvements Peripheral neuropathy Use of tobacco Treatment with lipid-lowering or hypoglycemic drugs Fibromyalgia Use of chronotropic or antihypertensive drugs Physically active subjects

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPA and DHA supplementation<br>EPA (1800mg/d) and DHA (1200mg/d) supplementation | Dietary Supplement: EPA and DHA supplementation<br>* Subjects will be given 3g/d (1,2g of DHA and 1,8g of EPA) - 5 capsules per day.<br>|
| Placebo Comparator: Placebo<br>Soy oil (3000 mg/d) | Dietary Supplement: Placebo<br>* Subjects will be given 3g/d of soy oil - 5 capsules per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clical features | Disease activity - assessed by SLEDAI score | 4 months | 
| Clinical features | Quality of life - assessed by SF-36 questionaire | 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 |