"Evaluation of the Effect of Vitamin E (α-tocopherol) Supplementation on Clinical Activity and Inflammation in Patients With Rheumatoid Arthritis"
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Levels of vitamin E
研究概览
简要总结
The objective of this clinical trial is to determine whether α-tocopherol (vitamin E) supplementation decreases inflammation and clinical activity in patients with rheumatoid arthritis (RA).The main questions to be answered are:
- Is supplementation with vitamin E (α-tocopherol) for one month associated with decreased clinical activity and inflammation in patients with RA?
Researchers will compare α-tocopherol with a placebo (a look-alike substance containing no active ingredient) to see if α-tocopherol effectively reduces inflammation and clinical activity in patients with rheumatoid arthritis.
Participants will:
- Take two capsules (one in the morning and one in the afternoon) of either α-tocopherol or placebo every day for a month.
- Attend clinic visits at the start of the intervention (baseline) and at the end of the month for final check-ups and tests.
- Keep a diary to record your symptoms and how often you take α-tocopherol or placebo.
详细描述
Background:
Rheumatoid arthritis (RA) RA is one of the most common autoimmune diseases, characterized by chronic inflammation of the sinovia, mainly of the small joints of the hand, wrists and feet. Chronic inflammation can lead to the destruction of cartilage and joint bone, causing joint deformity, functional disability, depression and significant economic costs for the affected individual.
α-tocopherol acetate: The α-tocopherol acetate is the most widely used analogue in food supplements because of its esterification gives it stability. The main function is antioxidant preventing lipid oxidation of cell membranes for this reason α-tocopherol is considered a possible protector against diseases related to oxidative processes such as chronic diseasedegenerative diseases such as diabetes mellitus, cancer, cardiovascular disease, rheumatic disease, neurological disease and ageing.
Vitamin E in RA: The role of vitamin E as a therapy in combination with RA treatment has been studied in several studies. Studies in mouse models of laminarin-induced arthritis have shown that supplementation with α-tocopherol decreases the expression of pro-inflammatory cytokines such as IL-6, TNF-α and MMPs. However, the mechanisms involved are unknown. There are few studies in RA patients where the effect of supplementation with α-tocopherol has been analyzed. In clinical trials, it has been observed that from 3 weeks with supplementation of α-tocopherol decreases the scales of clinical activity in addition to morning stiffness and joint pain even biochemical parameters such as acute phase reactants such as pCr and ESR. However, the effect on pro-inflammatory cytokines, autoantibodies and antioxidant effect has not been analyzed.
Research question: Is supplementation with Vitamin E (α-tocopherol) for one month associated with decreased clinical activity and inflammation in patients with RA?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Placebo use:
Participants will be informed that they may be taking vitamin E or placebo. Both vitamin E and placebo will have similar excipients and be masked by similar packaging.
- Double blind: It is important to minimize bias in the study that both the investigators involved as well as participants should be blinded as to who is receiving the active treatment and who is receiving the placebo. After the one-month period of supplementation and data collection, the study will be opened. An independent researcher to the project will be the one who keeps the information of the double blind.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •RA classification (ACR/EULAR 2010)
- •Early RA 2 years
- •Treatment with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations)
- •DAS28 ≥3.2
- •Vitamin E intake deficiency (<15mg/day)
- •No comorbidities
- •Age > 18 years
- •Voluntary participation and informed consent.
排除标准
- •Liver and kidney disease
- •Overlap syndrome
- •Coagulation disorders
- •Pregnancy
- •Consumption of supplements (iron, vitamin E, and K), and medications such as acetylsalicylic acid, amlodipine, estrogen, glucocorticoids and drugs used to treat dyslipidemias in the last three months.
- •Elimination Criteria:
- •Errors in administration of the 20% supplement
- •Adverse effects of the supplement
- •Pregnancy during the study
- •Insufficient blood sample
- •Voluntary withdrawal of informed consent.
研究组 & 干预措施
Intervention group
Treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus vitamin E 800mg/day.
干预措施: Will take vitamin E 800mg/day (Dietary Supplement)
Control group
Treated with conventional synthetic FARMEs (Metrotexato, Hydroxychloroquine, Leflunomide, Sulfasalazina and their combinations) plus the consumption of magnesium oxide 200mg/day in placebo form.
干预措施: Will take 200mg/day magnesium oxide placebo. (Drug)
结局指标
主要结局
Levels of vitamin E
时间窗: Exchange measures: Baseline and 1 month.
Adequacy:12 and 20 µg/mL (27.9-46.4 µmol/L). Insufficiency: 5 and 12 µg/mL (11.6-27.9 µmol/L). Minor deficiency of: 5 µg/mL (11.6 µmol/L).
次要结局
- C-reactive protein (pCr)(Exchange measures: Baseline and 1 month.)
- Erythrocyte sedimentation rate (ESR)(Exchange measures: Baseline and 1 month.)
- Auto- antibodies: Anti-CCP(Exchange measures: Baseline and 1 month.)
- Rheumatoid factor(Exchange measures: Baseline and 1 month.)
- Twenty-four hour reminder "questionnaire" (Recommended Daily Intake of Vitamin E)(Exchange measures: Baseline and 1 month.)
- Levels of: Proinflammatory cytokines ( IL-1β , IL-6 and TNF-α )(Exchange measures: Baseline and 1 month.)
- Antioxidant capacity: (DPPH, ABTS, FRAP and ORAC)(Exchange measures: Baseline and 1 month.)
- Index DAS-28(Exchange measures: Baseline and 1 month.)