Omega 3 in LES and APS

University of Sao Paulo

Status: Unknown

Conditions: Primary Antiphospholipid Syndrome; Systemic Lupus Erythematosus

Treatments: Dietary Supplement: EPA and DHA supplementation; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01956188

Omega 3 and SLE and APS USP

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

EPA and DHA supplementation

Experimental group

Description:

EPA (1800mg/d) and DHA (1200mg/d) supplementation

Treatment:

Dietary Supplement: EPA and DHA supplementation

Placebo

Placebo Comparator group

Description:

Soy oil (3000 mg/d)

Treatment:

Dietary Supplement: Placebo