Omega 3 in LES and APS
Primary Purpose
Systemic Lupus Erythematosus, Primary Antiphospholipid Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
EPA and DHA supplementation
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Systemic Lupus Erythematosus
Eligibility 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
Sites / Locations
- General Hospital - University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EPA and DHA supplementation
Placebo
Arm Description
EPA (1800mg/d) and DHA (1200mg/d) supplementation
Soy oil (3000 mg/d)
Outcomes
Primary Outcome Measures
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.
Endothelial function
Endothelial function assessed by flow mediated dilatation (FMD).
Secondary Outcome Measures
Clical features
Disease activity - assessed by SLEDAI score
Clinical features
Quality of life - assessed by SF-36 questionaire
Clinical features
Fatigue - assessed by 2 questionaires - Chalders´Fatigue Scale and Fatigue Severity Scale (FSS)
Clinical features
Body composition - lean (Kg) and fat mass (Kg) assessed by air displacement pletysmography (BOD POD).
Full Information
NCT ID
NCT01956188
First Posted
September 25, 2013
Last Updated
September 25, 2017
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01956188
Brief Title
Omega 3 in LES and APS
Official Title
Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Primary Antiphospholipid Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EPA and DHA supplementation
Arm Type
Experimental
Arm Description
EPA (1800mg/d) and DHA (1200mg/d) supplementation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Soy oil (3000 mg/d)
Intervention Type
Dietary Supplement
Intervention Name(s)
EPA and DHA supplementation
Intervention Description
Subjects will be given 3g/d (1,2g of DHA and 1,8g of EPA) - 5 capsules per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Subjects will be given 3g/d of soy oil - 5 capsules per day.
Primary Outcome Measure Information:
Title
Cytokine profile (serum levels of IL-1B, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-alpha, IFN-y)
Description
Cytokines´ serum levels (pg/ml) will be assessed by Elisa kits.
Time Frame
4 months
Title
Endothelial function
Description
Endothelial function assessed by flow mediated dilatation (FMD).
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Clical features
Description
Disease activity - assessed by SLEDAI score
Time Frame
4 months
Title
Clinical features
Description
Quality of life - assessed by SF-36 questionaire
Time Frame
4 months
Title
Clinical features
Description
Fatigue - assessed by 2 questionaires - Chalders´Fatigue Scale and Fatigue Severity Scale (FSS)
Time Frame
4 months
Title
Clinical features
Description
Body composition - lean (Kg) and fat mass (Kg) assessed by air displacement pletysmography (BOD POD).
Time Frame
4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
General Hospital - University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05.403-010
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
29552010
Citation
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.
Results Reference
derived
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Omega 3 in LES and APS
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