Omega 3 Fatty Acids and Systemic Lupus Erythematosus

NCT02524795 | Completed

• 1 other identifier: LES-001-O3
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Omega 3, Cytokines, Adipokines, Systemic lupus erythematosus

Outcome Measures

Primary Outcomes (3)

• Variations of serum cytokines related to omega 3 treatment

  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.

  Cytokines measurement on T0 (baseline) and T1 (after 12 weeks)

• Variations of serum adipokines related to omega 3 treatment

  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.

  Adipokines measurement on T0 (baseline) and T1 (after 12 weeks)

• Variations of serum C reactive protein related to omega 3 treatment

  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.

  C reactive protein measurement on T0 (baseline) and T1 (after 12 weeks)

Secondary Outcomes (1)

• Variations of biochemical markers related to omega 3 treatment

  Biochemical markers measurement on T0 (baseline) and T1 (after 12 weeks)

Study Arms (2)

Hiomega-3 supplement

EXPERIMENTAL

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 -

Control group

NO INTERVENTION

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.

Interventions

Hiomega-3 supplement of Naturalis® company - DIETARY_SUPPLEMENT

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.

Hiomega-3 supplement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Related Publications (1)

• Curado Borges M, de Miranda Moura Dos Santos F, Weiss Telles R, Melo de Andrade MV, Toulson Davisson Correia MI, Lanna CCD. Omega-3 fatty acids, inflammatory status and biochemical markers of patients with systemic lupus erythematosus: a pilot study. Rev Bras Reumatol Engl Ed. 2017 Nov-Dec;57(6):526-534. doi: 10.1016/j.rbre.2016.09.014. Epub 2016 Oct 22. English, Portuguese.

  PMID: 29173690 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maria Isabel TD Correia, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: August 17, 2015
• Study Start: March 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: March 1, 2014
• Last Updated: August 17, 2015

Record last verified: 2015-08