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Omega 3 in LES and APS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01956188
Recruitment Status : Unknown
Verified September 2017 by Fabiana Braga Benatti, University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : October 8, 2013
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Fabiana Braga Benatti, 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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Primary Antiphospholipid Syndrome Dietary Supplement: EPA and DHA supplementation Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 2014
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017


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.




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) [ Time Frame: 4 months ]
    Cytokines´ serum levels (pg/ml) will be assessed by Elisa kits.

  2. Endothelial function [ Time Frame: 4 months ]
    Endothelial function assessed by flow mediated dilatation (FMD).


Secondary Outcome Measures :
  1. Clical features [ Time Frame: 4 months ]
    Disease activity - assessed by SLEDAI score

  2. Clinical features [ Time Frame: 4 months ]
    Quality of life - assessed by SF-36 questionaire

  3. Clinical features [ Time Frame: 4 months ]
    Fatigue - assessed by 2 questionaires - Chalders´Fatigue Scale and Fatigue Severity Scale (FSS)

  4. Clinical features [ Time Frame: 4 months ]
    Body composition - lean (Kg) and fat mass (Kg) assessed by air displacement pletysmography (BOD POD).



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956188


Locations
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Brazil
General Hospital - University of Sao Paulo
Sao Paulo, SP, Brazil, 05.403-010
Sponsors and Collaborators
University of Sao Paulo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: October 8, 2013    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Antiphospholipid Syndrome
Syndrome
Disease
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases