Omega 3 Fatty Acids and Systemic Lupus Erythematosus
关键词
抽象
描述
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.
日期
最后验证: | 07/31/2015 |
首次提交: | 07/07/2015 |
提交的预估入学人数: | 08/12/2015 |
首次发布: | 08/16/2015 |
上次提交的更新: | 08/12/2015 |
最近更新发布: | 08/16/2015 |
实际学习开始日期: | 02/28/2009 |
预计主要完成日期: | 07/31/2012 |
预计完成日期: | 02/28/2014 |
状况或疾病
干预/治疗
Dietary Supplement: Hiomega-3 supplement
相
手臂组
臂 | 干预/治疗 |
---|---|
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 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. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | Female |
接受健康志愿者 | 是 |
标准 | 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 |
结果
主要结果指标
1. Variations of serum cytokines related to omega 3 treatment [Cytokines measurement on T0 (baseline) and T1 (after 12 weeks)]
2. Variations of serum adipokines related to omega 3 treatment [Adipokines measurement on T0 (baseline) and T1 (after 12 weeks)]
3. Variations of serum C reactive protein related to omega 3 treatment [C reactive protein measurement on T0 (baseline) and T1 (after 12 weeks)]
次要成果指标
1. Variations of biochemical markers related to omega 3 treatment [Biochemical markers measurement on T0 (baseline) and T1 (after 12 weeks)]