Whale Oil Versus Cod Liver Oil in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 主要终点
- To detect a difference in 10 mm on visual analogue scale (intensity of joint pain last week) between the two treatment groups
研究概览
简要总结
NSAIDS are associated with adverse GI effects and COX-2 inhibitors have cardiovascular risk. Long-term oral supplementation with fish oil reduce e.g. joint pain in rheumatoid arthritis (R.A) patients, with reduced need for NSAIDS, in addition to being cardioprotective. The aim is to investigate if 4 month supplementation of 15 ml/day of whale blubber oil compared with cod liver oil reduce the intensity of joint pain in patients with R.A (primary outcome). Patients are assessed at inclusion and after study (4 months) during routine polyclinical visit. Patients are called for interview after 6 and 12 weeks. Secondary outcomes are e.g. morning stiffness, quality of life and functional level
详细描述
Not relevant
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid arthritis patients according to American College of Rheumatology criteria (with active disease and in remission). Intensity of joint pain last week (30 mm or more on 100 mm Visual analogue scale). Stable use of DMARDS and no corticosteroid injections last 4 weeks before study and during study.
排除标准
- •Non-Norwegian speaking/reading or not understanding study design or non-compliance. Pregnant/lactating women. Bleeder disease, known HIV or hepatitis, medication with Marevan (blood thinner). Not willing or possible to stop taking regular omega-3 supplements during study.
结局指标
主要结局
To detect a difference in 10 mm on visual analogue scale (intensity of joint pain last week) between the two treatment groups
时间窗: At study end (4 months)
次要结局
- To detect a group difference in morning stiffness last week in minutes (720 min = 12 hours are limit for duration of morning stiffness recorded)(Study end (4 months))
- To detect a difference between groups in quality of life using SF-36(Study end (4 months))
- To see a group difference in functional level using MHAQ(Study end (4 months))
研究者
Marian Kjellevold
Head of Research
National Institute of Nutrition and Seafood Research, Norway