Omega 3 in LES and APS
Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 27, 2017
September 1, 2017
3.2 years
September 25, 2013
September 25, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
Endothelial function
Endothelial function assessed by flow mediated dilatation (FMD).
4 months
Secondary Outcomes (4)
Clical features
4 months
Clinical features
4 months
Clinical features
4 months
Clinical features
4 months
Study Arms (2)
EPA and DHA supplementation
EXPERIMENTALEPA (1800mg/d) and DHA (1200mg/d) supplementation
Placebo
PLACEBO COMPARATORSoy oil (3000 mg/d)
Interventions
Subjects will be given 3g/d (1,2g of DHA and 1,8g of EPA) - 5 capsules per day.
Eligibility Criteria
You may qualify if:
- Age between 7 and 40 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Hospital - University of Sao Paulo
São Paulo, São Paulo, 05.403-010, Brazil
Related Publications (1)
Felau SM, Sales LP, Solis MY, Hayashi AP, Roschel H, Sa-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.
PMID: 29552010DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
September 25, 2013
First Posted
October 8, 2013
Study Start
May 1, 2014
Primary Completion
July 1, 2017
Study Completion
December 1, 2017
Last Updated
September 27, 2017
Record last verified: 2017-09