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
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus Primary Antiphospholipid Syndrome||Dietary Supplement: EPA and DHA supplementation Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||December 2017|
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.
- 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).
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956188
|General Hospital - University of Sao Paulo|
|Sao Paulo, SP, Brazil, 05.403-010|