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

This study is not yet open for participant recruitment.
Verified October 2011 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01460680
First received: October 10, 2011
Last updated: October 25, 2011
Last verified: October 2011
History of Changes
  Purpose

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
Fibromyalgia
Systemic Lupus Erythematosus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia Lupus
Drug Information available for: Magnesium
U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Fatty acid composition of RBC membrane [ Time Frame: Within 2 weeks of obtaining blood sample ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460680

Locations
Israel
Tel Aviv Sourasky Medical Center Institute of Rheumatlogy Not yet recruiting
Tel Aviv, Israel
Contact: Jacob N Ablin, MD     972-3-6973668     jacobab@tasmc.health.gov.il    
Principal Investigator: Jacob N Ablin, MD            
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Jacob N Ablin, MD Tel-Aviv Sourasky Medical Center
  More Information

Publications:

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01460680     History of Changes
Other Study ID Numbers: 0391-11-TLV, 0391-11
Study First Received: October 10, 2011
Last Updated: October 25, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Fibromyalgia
Systemic Lupus Erythematosus
Omega-3 Fatty acids
Magnesium

Additional relevant MeSH terms:
Fibromyalgia
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

ClinicalTrials.gov processed this record on May 21, 2013