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Membrane Polyunsaturated Fatty Acid Content in Fibromyalgia and Systemic Lupus Erythematosus (SLE)

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. 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
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia Lupus

Fibromyalgia patients
Patients diagnosed as suffering from Fibromyalgia according to the ACR 1990 criteria
SLE patients
Patients diagnosed as suffering from Systemic Lupus Erythematosus by the ACR criteria
Healthy controls
Healthy controls

Primary Outcome Measures :
  1. 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
Blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 female patients attending the Fibromyalgia clinic 100 female patients diagnosed with SLE attending the rheumatology clinic 100 healthy female volunteers

Inclusion Criteria:

  • Inclusion criteria (fibromyalgia):

    1. Female adults, 18-80 years old
    2. Diagnosis of fibromyalgia per ACR1990 criteria (1)

Inclusion criteria (SLE):

  • Diagnosis of SLE according to the ACR criteria

Exclusion Criteria:

  • Exclusion criterion (for fibromyalgia patients):

    1. Other rheumatic disease (RA, SS, symptomatic osteoarthritis etc.)
    2. Other inflammatory disease associated with musculoskeletal pain (e.g. IBD)
    3. Painful neuropathic conditions (diabetic neuropathy, post-herpetic neuralgia etc.)
    4. Pregnancy or lactation
    5. Significant fluctuation in pain level over the previous ~3 months

Information from the National Library of Medicine

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 identifier (NCT number): NCT01460680

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Tel Aviv Sourasky Medical Center Institute of Rheumatlogy
Tel Aviv, Israel
Contact: Jacob N Ablin, MD    972-3-6973668   
Principal Investigator: Jacob N Ablin, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Principal Investigator: Jacob N Ablin, MD Tel-Aviv Sourasky Medical Center
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Responsible Party: Tel-Aviv Sourasky Medical Center Identifier: NCT01460680    
Other Study ID Numbers: 0391-11-TLV
0391-11 ( Other Identifier: Tel Aviv Sourasky Medical Center )
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: October 27, 2011
Last Verified: October 2011
Keywords provided by Tel-Aviv Sourasky Medical Center:
Systemic Lupus Erythematosus
Omega-3 Fatty acids
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Lupus Erythematosus, Systemic
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases