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Omega 3 Fatty Acids and Systemic Lupus Erythematosus (OM3LES)

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ClinicalTrials.gov Identifier: NCT02524795
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Cristina Costa Duarte Lanna, Federal University of Minas Gerais

Brief Summary:

Omega-3 fatty acids have been considered anti-inflammatory lipids based on data from epidemiological studies of Greenland Eskimos whose diet is rich in fish, sources of polyunsaturated fatty acids.

Fatty acids from the omega-3 family [mainly the α-linolenic acid, eicosapentaenoic (EPA) and docosahexaenoic (DHA)], as well as those of the omega-6 family [represented mainly by linoleic acid and arachidonic acid (AA)] are essential for the synthesis of eicosanoids, prostaglandins, leukotrienes, thromboxanes and other oxidative factors, major mediators and regulators of inflammation.

Systemic lupus erythematosus (SLE) is an inflammatory autoimmune disease characterized by the loss of balance of cellular immunoregulation and increased levels of circulating inflammatory mediators.Thus, omega-3 supplementation could represent additional therapy for individuals with SLE.

The aim of this study was to investigate the effects of omega-3 fatty acids on circulating levels of inflammatory and biochemical markers in women with SLE.


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Dietary Supplement: Hiomega-3 supplement of Naturalis® company - Not Applicable

Detailed Description:

This is a pilot clinical trial of omega-3-polyunsaturated fatty acids carried out in SLE patients followed at the Rheumatology Unit of Hospital das Clínicas, Universidade Federal de Minas Gerais, UFMG.

Female patients who met the revised American College of Rheumatology (ACR) classification criteria for SLE (1982/1997)15, age over 18 years old and below 60 years old, who were taking stable doses of medications for the SLE treatment in the last three months were included. Exclusion criteria were the following: pregnancy, disease duration of less than one year, allergy to fish, fish oil or any omega-3 product, omega-3 use within the previous six months and diagnosis of diabetes mellitus, liver disease, chronic renal failure, any type of infection at enrollment and/or throughout the study.

A 12 week pilot clinical trial of omega-3 fatty acid supplementation was conducted. Participants were seen at baseline (T0) and at week 12 (T1) for clinical, laboratory and nutritional assessment. Participants were also contacted by telephone in week 6 to check on compliance and any adverse events. The patients were randomized into one of two groups in a 1:1 ratio. Patients in the study group received, throughout 12 weeks, two tablets per day of omega-3 fatty acids (540mg of EPA and DHA of 100mg; Hiomega-3 supplement of Naturalis® company - registered in the National Health Department number 4.1480.0006.001-4). Patients in the control group did not receive the nutrient nor any kind of placebo. All participants were instructed not to take omega-3 rich foods during the study period. The researcher (FMMS) who did clinical assessment and the inflammatory and biochemical data assessment was blind to randomization and intervention.

Variables measured at each visit included: disease activity index, using the Systemic Lupus Disease Activity Index (SLEDAI-2k)16; damage index (Systemic Lupus International Collaboration Clinics/American College of Rheumatology damage index - SLICC/ACR)17; fasting lipid and glucose profile; standard laboratory tests to assess SLE (red and white blood count, platelet count, creatinine, urinalysis, urine protein/creatinine ratio, anti-dsDNA, anticardiolipin, C3 and C4 levels); cytokines (IL-6, IL-10), adipokines (leptin, adiponectin) C-reactive protein (CRP), nutritional assessment, and in use medications.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Omega 3 Fatty Acids, Inflammatory Status and Biochemical Markers of Patients With Systemic Lupus Erythematosus: a Pilot Study
Study Start Date : March 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hiomega-3 supplement

Patients in the study group received, throughout 12 weeks, two tablets per day of omega-3 fatty acids (540mg of EPA and DHA of 100mg; Hiomega-3 supplement of Naturalis® company). Participants were seen at baseline (T0) and at week 12 (T1) for clinical, laboratory and nutritional assessment.

Variables measured at each visit included: disease activity index, using the Systemic Lupus Disease Activity Index (SLEDAI-2k)16; damage index (Systemic Lupus International Collaboration Clinics/American College of Rheumatology damage index - SLICC/ACR)17; fasting lipid and glucose profile; standard laboratory tests to assess SLE ; cytokines (IL-6, IL-10), adipokines (leptin, adiponectin) C-reactive protein (CRP), nutritional assessment, and in use medications.

Dietary Supplement: Hiomega-3 supplement of Naturalis® company -
Patients (N=22) were seen at baseline (T0) and at week 12 (T1) for clinical, laboratory and nutritional assessment, and were contacted by telephone in week 6 to check on compliance and any adverse events. Patients received, throughout 12 weeks, two tablets per day of omega-3 fatty acids (540mg of EPA and DHA of 100mg; Hiomega-3 supplement of Naturalis® company - registered in the National Health Department number 4.1480.0006.001-4). All participants were instructed not to take omega-3 rich foods during the study period.

No Intervention: Control group

Patients in the control group did not receive the nutrient nor any kind of placebo. They were seen at baseline (T0) and at week 12 (T1) for clinical, laboratory and nutritional assessment.

Variables measured at each visit included: disease activity index, using the Systemic Lupus Disease Activity Index (SLEDAI-2k)16; damage index (Systemic Lupus International Collaboration Clinics/American College of Rheumatology damage index - SLICC/ACR)17; fasting lipid and glucose profile; standard laboratory tests to assess SLE ; cytokines (IL-6, IL-10), adipokines (leptin, adiponectin) C-reactive protein (CRP), nutritional assessment, and in use medications.




Primary Outcome Measures :
  1. Variations of serum cytokines related to omega 3 treatment [ Time Frame: Cytokines measurement on T0 (baseline) and T1 (after 12 weeks) ]
    The primary outcomes was median (interquartile range, IQR) variations [ΔV=pre-Treatment (T0) minus post-treatment (T1) concentrations] of serum cytokines (IL6 e IL 10) after 12 weeks of treatment between groups.

  2. Variations of serum adipokines related to omega 3 treatment [ Time Frame: Adipokines measurement on T0 (baseline) and T1 (after 12 weeks) ]
    The primary outcomes was median (interquartile range, IQR) variations [ΔV=pre-Treatment (T0) minus post-treatment (T1) concentrations] of serum adipokines (leptin and adiponectin) after 12 weeks of treatment between groups.

  3. Variations of serum C reactive protein related to omega 3 treatment [ Time Frame: C reactive protein measurement on T0 (baseline) and T1 (after 12 weeks) ]
    The primary outcomes was median (interquartile range, IQR) variations [ΔV=pre-Treatment (T0) minus post-treatment (T1) concentrations] of serum C reactive protein after 12 weeks of treatment between groups.


Secondary Outcome Measures :
  1. Variations of biochemical markers related to omega 3 treatment [ Time Frame: Biochemical markers measurement on T0 (baseline) and T1 (after 12 weeks) ]
    The primary outcomes was median (interquartile range, IQR) variations [ΔV=pre-Treatment (T0) minus post-treatment (T1) concentrations] of biochemical markers (glucose and lipidis) after 12 weeks of treatment between groups.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: 1-Diagnosis of lupus according to American College of Rheumatology (ACR) classification criteria for SLE (1982/1997)

  • Taking stable doses of medications for the SLE treatment in the last three months.

Exclusion Criteria:

  • pregnancy, disease duration of less than one year, allergy to fish, fish oil or any omega-3 product, omega-3 use within the previous six months and diagnosis of diabetes mellitus, liver disease, chronic renal failure, any type of infection at enrollment and/or throughout the study

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 ClinicalTrials.gov identifier (NCT number): NCT02524795


Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
Principal Investigator: Maria Isabel TD Correia, PhD Federal University of Minas Gerais

Responsible Party: Cristina Costa Duarte Lanna, MD, PhD, Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02524795     History of Changes
Other Study ID Numbers: LES-001-O3
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015

Keywords provided by Cristina Costa Duarte Lanna, Federal University of Minas Gerais:
Omega 3, Cytokines, Adipokines, Systemic lupus erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases