Omega 3 in LES and APS

September 25, 2017 updated by: Fabiana Braga Benatti, University of Sao Paulo

Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05.403-010
        • General Hospital - University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months
Endothelial function
Time Frame: 4 months
Endothelial function assessed by flow mediated dilatation (FMD).
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clical features
Time Frame: 4 months
Disease activity - assessed by SLEDAI score
4 months
Clinical features
Time Frame: 4 months
Quality of life - assessed by SF-36 questionaire
4 months
Clinical features
Time Frame: 4 months
Fatigue - assessed by 2 questionaires - Chalders´Fatigue Scale and Fatigue Severity Scale (FSS)
4 months
Clinical features
Time Frame: 4 months
Body composition - lean (Kg) and fat mass (Kg) assessed by air displacement pletysmography (BOD POD).
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2014

Primary Completion (ACTUAL)

July 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

October 1, 2013

First Posted (ESTIMATE)

October 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Omega 3 and SLE and APS USP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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