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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

Tracking Information
First Submitted Date  ICMJE September 25, 2013
First Posted Date  ICMJE October 8, 2013
Last Update Posted Date September 27, 2017
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
  • 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.
  • Endothelial function [ Time Frame: 4 months ]
    Endothelial function assessed by flow mediated dilatation (FMD).
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2013)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2013)
  • Clical features [ Time Frame: 4 months ]
    Disease activity - assessed by SLEDAI score
  • Clinical features [ Time Frame: 4 months ]
    Quality of life - assessed by SF-36 questionaire
  • Clinical features [ Time Frame: 4 months ]
    Fatigue - assessed by 2 questionaires - Chalders´Fatigue Scale and Fatigue Severity Scale (FSS)
  • Clinical features [ Time Frame: 4 months ]
    Body composition - lean (Kg) and fat mass (Kg) assessed by air displacement pletysmography (BOD POD).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega 3 in LES and APS
Official Title  ICMJE Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Systemic Lupus Erythematosus
  • Primary Antiphospholipid Syndrome
Intervention  ICMJE
  • 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.
  • Dietary Supplement: Placebo
    Subjects will be given 3g/d of soy oil - 5 capsules per day.
Study Arms  ICMJE
  • Experimental: EPA and DHA supplementation
    EPA (1800mg/d) and DHA (1200mg/d) supplementation
    Intervention: Dietary Supplement: EPA and DHA supplementation
  • Placebo Comparator: Placebo
    Soy oil (3000 mg/d)
    Intervention: Dietary Supplement: Placebo
Publications * Felau SM, Sales LP, Solis MY, Hayashi AP, Roschel H, Sá-Pinto AL, Andrade DCO, Katayama KY, Irigoyen MC, Consolim-Colombo F, Bonfa E, Gualano B, Benatti FB. Omega-3 Fatty Acid Supplementation Improves Endothelial Function in Primary Antiphospholipid Syndrome: A Small-Scale Randomized Double-Blind Placebo-Controlled Trial. Front Immunol. 2018 Mar 2;9:336. doi: 10.3389/fimmu.2018.00336. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 25, 2017)
22
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2013)
60
Estimated Study Completion Date  ICMJE December 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01956188
Other Study ID Numbers  ICMJE Omega 3 and SLE and APS USP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fabiana Braga Benatti, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP