Omega 3 Fatty Acids and Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

— OM3LES  

Official title:

Omega 3 Fatty Acids, Inflammatory Status and Biochemical Markers of Patients With Systemic Lupus Erythematosus: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524795
• Other study ID #: LES-001-O3
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: August 13, 2015
• Start date: March 2009
• Est. completion date: March 2014

Study information

• Verified date: August 2015
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2014
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria: 1-Diagnosis of lupus according to American College of Rheumatology (ACR) classi?cation 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 ?sh, ?sh 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variations of serum cytokines related to omega 3 treatment	The primary outcomes was median (interquartile range, IQR) variations [?V=pre-Treatment (T0) minus post-treatment (T1) concentrations] of serum cytokines (IL6 e IL 10) after 12 weeks of treatment between groups.	Cytokines measurement on T0 (baseline) and T1 (after 12 weeks)	No
Primary	Variations of serum adipokines related to omega 3 treatment	The primary outcomes was median (interquartile range, IQR) variations [?V=pre-Treatment (T0) minus post-treatment (T1) concentrations] of serum adipokines (leptin and adiponectin) after 12 weeks of treatment between groups.	Adipokines measurement on T0 (baseline) and T1 (after 12 weeks)	No
Primary	Variations of serum C reactive protein related to omega 3 treatment	The primary outcomes was median (interquartile range, IQR) variations [?V=pre-Treatment (T0) minus post-treatment (T1) concentrations] of serum C reactive protein after 12 weeks of treatment between groups.	C reactive protein measurement on T0 (baseline) and T1 (after 12 weeks)	No
Secondary	Variations of biochemical markers related to omega 3 treatment	The primary outcomes was median (interquartile range, IQR) variations [?V=pre-Treatment (T0) minus post-treatment (T1) concentrations] of biochemical markers (glucose and lipidis) after 12 weeks of treatment between groups.	Biochemical markers measurement on T0 (baseline) and T1 (after 12 weeks)	Yes