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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

Tracking Information
First Submitted Date  ICMJE July 8, 2015
First Posted Date  ICMJE August 17, 2015
Last Update Posted Date August 17, 2015
Study Start Date  ICMJE March 2009
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2015)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega 3 Fatty Acids and Systemic Lupus Erythematosus
Official Title  ICMJE Omega 3 Fatty Acids, Inflammatory Status and Biochemical Markers of Patients With Systemic Lupus Erythematosus: a Pilot Study
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Dietary Supplement: Hiomega-3 supplement of Naturalis® company -
  • 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.

Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2015)
49
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02524795
Other Study ID Numbers  ICMJE LES-001-O3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cristina Costa Duarte Lanna, Federal University of Minas Gerais
Study Sponsor  ICMJE Federal University of Minas Gerais
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria Isabel TD Correia, PhD Federal University of Minas Gerais
PRS Account Federal University of Minas Gerais
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP