NCT01352013已完成2 期
The Impact of Omega-3 Fatty Acid Supplements on Fibromyalgia (FM) Symptoms: A Randomized, Double-blind, Placebo-controlled Exploratory Study.
Dr. Yoram Shir2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Visual analog scale (VAS)
研究概览
简要总结
The purpose of this study is to find out if omega-3 fatty acid supplements are more effective than an inactive placebo at reducing pain, reducing fatigue and elevating mood in patients with fibromyalgia.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-
- •A diagnosis of FM according to the American College of Rheumatology classification criteria(Wolfe et al., 1990)
- •Negative urine pregnancy test at enrolment and willingness not to become pregnant for the duration of the study.
- •Pain levels of at least 4 on 10-cm VAS at the time of recruitment.
- •Ability to communicate in English or in French.
- •Willing to sign an informed consent.
- •If the patient is taking medication or natural health product (excluding omega-3 containing products) to treat fibromyalgia, she must be on a stable regimen for a minimum of two weeks before recruitment and be willing to keep this stable medication or natural health product regimen throughout the study period.
- •If the patient is using other therapies to treat fibromyalgia such as TENS, acupuncture, exercise, psychotherapy, massage, physiotherapy, etc, she must be doing so for a minimum of two weeks before recruitment and be willing to continue those therapies throughout the study period.
排除标准
- •Use of anticoagulants (Coumadin® or Plavix®), having a bleeding disorder or being scheduled for a surgical procedure. This is because omega-3 fatty acids can prolong bleeding time, although doses we propose to use are safe (see Risks section)
- •Allergy to fish, olive oil, medium chain triglycerides, lemon, green tea, vitamin E or tylenol
- •Past (within the last year) or present specific dietary supplementation with omega-3 fish oil or other natural health products containing omega-3 fatty acids (e.g. flax seed oil, krill oil, etc) or regularly eating more than two fatty fish meals/week (salmon, mackerel, sardine, flounder, herring, or any other fish considered to have a high level of omega-3 fatty acids).
- •Patient enrolled in another research study involving any treatment.
- •Patient engaged in active litigation
- •Regular use of recreational drugs
- •Alcohol consumption > 10 units/week
- •Morbidly obese patients
- •Pregnancy or breastfeeding
- •Uncontrolled major medical conditions. Neurological problems. Current psychiatric condition. Chronic pain condition other than FM.
结局指标
主要结局
Visual analog scale (VAS)
时间窗: 2 months
Pain intensity
次要结局
- Beck Depression Inventory (BDI)(2 months)
- Profile of Mood States (POMS)(2 months)
- Visual analog scales (VAS)(2 months)
- Fibromyalgia Impact Questionnaire(2 months)
- Use of rescue medication(2 months)
- Multidimensional Fatigue Inventory (MFI-20)(2 months)
研究者
Dr. Yoram Shir
Doctor
McGill University Health Centre/Research Institute of the McGill University Health Centre
研究点 (2)
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