Omega 3 in LES and APS

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01956188

Enrollment

Registered

2013-10-08

Start date

2014-05-31

Completion date

2017-12-31

Last updated

2017-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Antiphospholipid Syndrome, Systemic Lupus Erythematosus

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.

Interventions

DIETARY_SUPPLEMENTEPA and DHA supplementation

Subjects will be given 3g/d (1,2g of DHA and 1,8g of EPA) - 5 capsules per day.

DIETARY_SUPPLEMENTPlacebo

Subjects will be given 3g/d of soy oil - 5 capsules per day.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026