Omega 3 in LES and APS

Not Applicable

• Conditions: Systemic Lupus Erythematosus; Primary Antiphospholipid Syndrome
• Interventions: Dietary Supplement: EPA and DHA supplementation; Dietary Supplement: Placebo

• Registration Number: NCT01956188
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-09-25
• Study First Submitted QC: 2013-10-01
• Study First Posted: 2013-10-08
• Study Start: 2014-05
• Primary Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-25
• Last Update Posted: 2017-09-27
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• Age between 7 and 40 years

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPA and DHA supplementation	EPA and DHA supplementation	EPA (1800mg/d) and DHA (1200mg/d) supplementation
Placebo	Placebo	Soy oil (3000 mg/d)

Primary Outcome Measures

Name	Time	Method
Cytokine profile (serum levels of IL-1B, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-alpha, IFN-y)	4 months	Cytokines´ serum levels (pg/ml) will be assessed by Elisa kits.
Endothelial function	4 months	Endothelial function assessed by flow mediated dilatation (FMD).

Secondary Outcome Measures

Name	Time	Method
Clical features	4 months	Disease activity - assessed by SLEDAI score
Clinical features	4 months	Body composition - lean (Kg) and fat mass (Kg) assessed by air displacement pletysmography (BOD POD).

Trial Locations

Locations (1)

General Hospital - University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil