Omega 3 in LES and APS

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01956188
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 43
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus; Primary Antiphospholipid Syndrome	Dietary Supplement: EPA and DHA supplementation; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: Jul 1, 2017
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EPA and DHA supplementation EPA (1800mg/d) and DHA (1200mg/d) supplementation	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 Comparator: Placebo Soy oil (3000 mg/d)	Dietary Supplement: Placebo; Subjects will be given 3g/d of soy oil - 5 capsules per day.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Endothelial function [4 months]

   Endothelial function assessed by flow mediated dilatation (FMD).

Secondary Outcome Measures

1. Clical features [4 months]

   Disease activity - assessed by SLEDAI score

2. Clinical features [4 months]

   Quality of life - assessed by SF-36 questionaire

3. Clinical features [4 months]

   Fatigue - assessed by 2 questionaires - Chalders´Fatigue Scale and Fatigue Severity Scale (FSS)

4. Clinical features [4 months]

   Body composition - lean (Kg) and fat mass (Kg) assessed by air displacement pletysmography (BOD POD).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital - University of Sao Paulo	Sao Paulo	SP	Brazil	05.403-010

Sponsors and Collaborators

• University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fabiana Braga Benatti, PhD, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT01956188
• Other Study ID Numbers: Omega 3 and SLE and APS USP
• First Posted: Oct 8, 2013
• Last Update Posted: Sep 27, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Antiphospholipid Syndrome; Syndrome

Study Results

No Results Posted as of Sep 27, 2017