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Omega 3 in LES and APS

NCT ID: NCT01956188

Last Updated: 2017-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Systemic Lupus Erythematosus Primary Antiphospholipid Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EPA and DHA supplementation

EPA (1800mg/d) and DHA (1200mg/d) supplementation

Group Type EXPERIMENTAL

EPA and DHA supplementation

Intervention Type DIETARY_SUPPLEMENT

Subjects will be given 3g/d (1,2g of DHA and 1,8g of EPA) - 5 capsules per day.

Placebo

Soy oil (3000 mg/d)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Subjects will be given 3g/d of soy oil - 5 capsules per day.

Interventions

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EPA and DHA supplementation

Subjects will be given 3g/d (1,2g of DHA and 1,8g of EPA) - 5 capsules per day.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Subjects will be given 3g/d of soy oil - 5 capsules per day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Fabiana Braga Benatti

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General Hospital - University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 29552010 (View on PubMed)

Other Identifiers

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Omega 3 and SLE and APS USP

Identifier Type: -

Identifier Source: org_study_id