Comparison of the Effects of Simultaneous Administration of Vitamin E and Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Classification of functional status in RA according to revised criteria of the American
研究概览
简要总结
The purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis.
详细描述
The purpose of this study is to determine whether simultaneous supplementation with omega-3 fatty acids and vitamin E is effective in the treatment of patients with rheumatoid arthritis.
Most of studies on omega-3 fatty acids (omega-3) supplementation in patients with rheumatoid arthritis (RA) have clearly shown potentially beneficial changes in cytokine and eicosanoid metabolism. The overall clinical improvement, however, has been only moderate. One explanation is that an increased intake of omega-3 leads to a reduction in the availability of antioxidants and an increased generation of lipid peroxides. The majority of the anti-inflammatory drugs routinely used nowadays are COX (cyclo-oxygenase) inhibitors. Mechanism of COX II inhibitors is similar of omega-3. So, it is difficult to differentiate omega-3 net effects in some situations. Existing clinical trials on omega-3 and vitamin E (Vit E) are sometimes questioned due to using omega-6 fatty acids as placebo and neglecting omega-6 fatty acid intake in the diet. A comprehensive randomized controlled double-blind trial would have omega-6 fatty acids served as placebo in patients who are well matched in terms of therapies and drugs.
Comparison(s): Comparison of groups supplemented with omega-3, omega-3 with Vit E, and placebo (Medium chain triglycerides: MCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of rheumatoid arthritis according American college of rheumatology (ACR)
排除标准
- •Infection
- •Major joint malformations
- •Simultaneous diseases like metabolic and gastrointestinal
- •Being class IV according to ACR
- •Drug dose fluctuations
- •History of Vit E and/or omega-3 supplements during past six months
- •Gastric irrigations
研究组 & 干预措施
未命名试验
干预措施: Omega-3 and Vitamin E supplementation (Drug)
结局指标
主要结局
Classification of functional status in RA according to revised criteria of the American
College of Rheumatology at 0, 6 and 12 weeks
Patient's satisfaction in activities of daily living based on a Persian version of Health Assessment Questionnaire (PE-HAQ) at 0, 6 and 12 weeks
Score on Persian version of health assessment questionnaire (PE-HAQ) at 0, 6 and 12 weeks
Disease activity score at 0, 6 and 12 weeks
Duration of morning stiffness (in minutes) at 0, 6 and 12 weeks
Joint pain intensity, on a five-point scale (0, absent) at 0, 6 and 12 weeks
Onset of fatigue (in minutes) after walking at 0, 6 and 12 weeks
Ritchie's articular index for pain joints at 0, 6 and 12 weeks
Right and left grip strength (in mmHg) measured with a sphygmomanometer cuff inflated to 20 mmHg at 0, 6 and 12 weeks
Patient's global assessment of disease activity (0 to 10 cm visual analog scale: 0, symptom free; 10, very severe) at 0, 6 and 12 weeks
次要结局
- TNF-alpha at 0, 6 and 12 weeks
- IL-1 beta at 0, 6 and 12 weeks
- C-reactive protein at 0, 6 and 12 weeks
- Erythrocyte sedimentation rate at 0, 6 and 12 weeks
- Malondialdehyde at 0, 6 and 12 weeks
- Systolic blood pressure at 0, 6 and 12 weeks
- Diastolic blood pressure at 0, 6 and 12 weeks