Membrane Polyunsaturated Fatty Acid Content in Fibromyalgia and Systemic Lupus Erythematosus (SLE)
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|ClinicalTrials.gov Identifier: NCT01460680|
Recruitment Status : Unknown
Verified October 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : October 27, 2011
Last Update Posted : October 27, 2011
Polyunsaturated omega-3 fatty acids (ω3 PUFAs) are essential nutrients. Studies indicate that the incidence of Major Depression (MD) is inversely related to the consumption of fish (which are rich in ω3-PUFAs) and to the concentration of ω3 PUFAs in the plasma or Red Blood Cell (RBC) membranes. In several studies, the ω6 to ω3 ratio was elevated (ω6 PUFAs are pro-inflammatory, compared to ω3). ω3 PUFAs are also inversely associated with anxiety and neuroticism but apparently not with somatization.
Supplementation of fish oil alleviates joint pain in patients with auto-immune disease. Inhibition of pro-inflammatory cytokines (which induce both pain and depression-like symptoms) by ω3 PUFAs may underlie the benefit conferred by fish oil consumption . RBC ω3 PUFA content is lower in patients with Systemic Lupus Erythematosus and chronic fatigue syndrome, compared to healthy controls. The ω3 PUFA status of fibromyalgia patients has not been assessed.
Magnesium is an essential nutrient and plays a regulatory role in neural transmission. It is not known whether magnesium concentration is associated with pain in humans.
The objectives of the current study are to 1) compare the mean RBC omega-3 content in female fibromyalgia patients compared to that of healthy controls and female SLE patients, and to 2) assess the correlation between RBC omega-3 content and between the severity of physical (e.g. pain) and mental (e.g. depression) in fibromyalgia and Systemic Lupus Erythematosus (SLE).
|Condition or disease|
|Fibromyalgia Systemic Lupus Erythematosus|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Association of Membrane Polyunsaturated Fatty Acid Content and Intracellular Magnesium Concentration With Mental and Physical Symptoms in Fibromyalgia and SLE: a Case-control Study|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||June 2013|
Patients diagnosed as suffering from Fibromyalgia according to the ACR 1990 criteria
Patients diagnosed as suffering from Systemic Lupus Erythematosus by the ACR criteria
- Fatty acid composition of RBC membrane [ Time Frame: Within 2 weeks of obtaining blood sample ]5 mls of blood centrifuged at 4000 rpm for 10 min at 5 o C, removal of plasma and buffy coat; addition of 5 ml cold saline + EDTA ; centrifuge at 3000 rpm for 10 min at 5oC; repeat; flushing of erythrocytes with N2; storage at -70o C . Lipid extraction by homogenization in hexane/ isopropanol. Fatty acid analysis: fatty acids will be converted to methyl esters by heating with BF3 in methanol, and the methyl esters separated on a HP 5890 Series II Gas Chromatograph containing a flame ionization detector..
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460680
|Tel Aviv Sourasky Medical Center Institute of Rheumatlogy|
|Tel Aviv, Israel|
|Contact: Jacob N Ablin, MD 972-3-6973668 firstname.lastname@example.org|
|Principal Investigator: Jacob N Ablin, MD|
|Principal Investigator:||Jacob N Ablin, MD||Tel-Aviv Sourasky Medical Center|