NCT01618019已完成不适用
Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Dose of NSAID
研究概览
简要总结
The purpose of this study is to see if supplementation of n-3 polyunsaturated fatty acid (PUFA) can be beneficial for the patients with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with rheumatoid arthritis diagnosed based on American College of Rheumatology guideline and receiving NSAID, glucocorticoids, or DMARD were eligible if the dosage had been stable for at least 3 months prior to entering the study.
排除标准
- •Patients were excluded if they were pregnant, lactating, under the age of 18 or over age 80, taking supplements containing n-3 PUFA, white blood cell (WBC) ≤ 3.5 × 109/L, hemoglobin (Hb) ≤ 8.5 g/dL, platelet ≤ 100 × 109/L, creatinine ≥ 2.0 mg/dL, and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 times upper limit of normal.
结局指标
主要结局
Dose of NSAID
时间窗: 16 week
Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day
次要结局
- BSAP Concentration(16 week)
- CTX Concentration(16 week)
- Duration of Morning Stiffness(16 week)
- Physician's Global Assessment(16 week)
- Patient's Global Assessment(16 week)
- Pain Scale(16 week)
- Osteocalcin Concentration(16 week)
研究者
Yongsoon Park
Associate Professor
Hanyang University
研究点 (2)
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