Omega 3 in LES and APS

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01956188
• Other study ID #: Omega 3 and SLE and APS USP
• Status: Active, not recruiting
• Phase: N/A
• First received: September 25, 2013
• Last updated: September 25, 2017
• Start date: May 2014
• Est. completion date: December 2017

Study information

• Verified date: September 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Lupus Erythematosus, Systemic
• Primary Antiphospholipid Syndrome
• Syndrome
• Systemic Lupus Erythematosus

Intervention

Dietary Supplement:
• EPA and DHA supplementation
Subjects will be given 3g/d (1,2g of DHA and 1,8g of EPA) - 5 capsules per day.
• Placebo
Subjects will be given 3g/d of soy oil - 5 capsules per day.

Locations

Country	Name	City	State
Brazil	General Hospital - University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Endothelial function	Endothelial function assessed by flow mediated dilatation (FMD).	4 months
Secondary	Clical features	Disease activity - assessed by SLEDAI score	4 months
Secondary	Clinical features	Quality of life - assessed by SF-36 questionaire	4 months
Secondary	Clinical features	Fatigue - assessed by 2 questionaires - Chalders´Fatigue Scale and Fatigue Severity Scale (FSS)	4 months
Secondary	Clinical features	Body composition - lean (Kg) and fat mass (Kg) assessed by air displacement pletysmography (BOD POD).	4 months