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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 August 2015 |
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Main ID: |
NCT02524795 |
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Date of registration:
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08/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Omega 3 Fatty Acids and Systemic Lupus Erythematosus
OM3LES |
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Scientific title:
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Omega 3 Fatty Acids, Inflammatory Status and Biochemical Markers of Patients With Systemic Lupus Erythematosus: a Pilot Study |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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49 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02524795 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Contacts
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Name:
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Maria Isabel TD Correia, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Minas Gerais |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Dietary Supplement: Hiomega-3 supplement of Naturalis® company -
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Primary Outcome(s)
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Variations of serum cytokines related to omega 3 treatment
[Time Frame: Cytokines measurement on T0 (baseline) and T1 (after 12 weeks)]
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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)]
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Variations of serum adipokines related to omega 3 treatment
[Time Frame: Adipokines measurement on T0 (baseline) and T1 (after 12 weeks)]
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Secondary Outcome(s)
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Variations of biochemical markers related to omega 3 treatment
[Time Frame: Biochemical markers measurement on T0 (baseline) and T1 (after 12 weeks)]
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Secondary ID(s)
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LES-001-O3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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