The Effect of Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis: A Study Protocol of a Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- impact of omega3 supplementation on rheumatoid arthritis activity
研究概览
简要总结
The aim of this double-blinded randomized controlled trial (RCT) was to assess the effect of omega-3 intake versus placebo among patients with RA on the primary outcome of disease activity, and the secondary outcomes of function, fatigue and sleep.
This is a prospective, comparative, randomized study, that will be conducted in a single centre (the Rheumatology Department of Charles Nicolle Hospital) during a period of 10 months.
This double-blinded RCT will include adult patients diagnosed with RA according to the Association of Rheumatology America (ACR) criteria, attending the Rheumatology Department of Charles Nicolle Hospital.
All included patients will be randomized into two groups: an intervention group who will receive omega-3 supplementation and a control group who will receive placebo supplementation, over a period of 3 months.
The placebo capsules will be olive oil-based and will have the same visual as the omega-3 capsules. They will be developed by Vital Company.
Patients in the intervention group will consume 2 omega-3 capsules daily, which contain 36% and 24% of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively.
The dose of omega-3 and placebo will be constant throughout the study period.
Patients will be evaluated at baseline and after 3 months of omega-3 or placebo intake, by a questionnaire performed by a research assistant, which contains the following evaluation parameters:
- Assessment of dietary and non-study supplemental intakes of marine omega-3 fatty acids
- Assessment of disease activity
- Assessment of function
- Assessment of sleep quality
- Assessment of fatigue
详细描述
Objective:
The aim of this double-blinded randomized controlled trial (RCT) will be to assess the effect of omega-3 intake versus placebo among patients with RA on the primary outcome of disease activity, and the secondary outcomes of function, fatigue and sleep.
Study design This is a prospective, comparative, randomized study, that will be conducted in a single centre (the Rheumatology Department of Charles Nicolle Hospital) during a period of 10 months (from May 2025 to February 2026).
Patients This double-blinded RCT will include adult patients diagnosed with RA according to the Association of Rheumatology America (ACR) criteria, attending the Rheumatology Department of Charles Nicolle Hospital. Concomitant use of synthetic and/or biologic disease modifying antirheumatic drugs (DMARDs) and symptomatic treatments (low dose of corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs)) is permitted by maintaining a stable dose during the study period.
Non-inclusion criteria will be allergy to fish and seafood, treatment with anticoagulants and coagulation disorders, severe hypertriglyceridemia associated with pancreatitis, severe hepatic impairment, severe renal impairment, and current pregnancy or breastfeeding.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Adult patients ≥ 18 years
- •Patients diagnosed with RA according to the Association of Rheumatology America (ACR) criteria, attending the Rheumatology Department of Charles Nicolle Hospital.
排除标准
- •Patients with allergy to fish and seafood
- •Patients treated with anticoagulants and coagulation disorders
- •Patients with severe hypertriglyceridemia associated with pancreatitis
- •Patients with severe hepatic impairment
- •Patients with severe renal impairment
- •Current pregnancy or breastfeeding.
研究组 & 干预措施
control group
The control group will receive placebo supplementation, over a period of 3 months. The placebo capsules will be olive oil-based and will have the same visual as the omega-3 capsules. They will be developed by Vital Company. The dose of placebo will be constant throughout the study period.
干预措施: Placebo (Other)
omega3 group
Patients in the intervention group will consume 2 omega-3 capsules daily, which contain 36% and 24% of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively, during a period of 3 months.
The dose of omega-3 will be constant throughout the study period.
干预措施: Omega-3 Supplementation (Dietary Supplement)
结局指标
主要结局
impact of omega3 supplementation on rheumatoid arthritis activity
时间窗: Rheumatoid arthritis activity will be evaluated at baseline and at the end of the protocol (3 months of supplementation)
Patients will be evaluated by the disease Activity Score (DAS28). This combined index measures disease activity in patients with RA. It includes a 28 tender joint count, a 28 swollen joint count, a general assessment of the patient's general health status and the level of CRP. The score is interpreted as follow: less than 2.6: RA is in remission, 2.6 to 3.2: a low level of disease activity, more than 3.2: moderate disease activity, more than 5.1: very active disease.
次要结局
- effect of omega3 supplementation on rheumatoid arthritis function(Function in rheumatoid arthrtis will be evaluated at baseline and then 3 months later)
- effect of omega3 supplementation on fatigue during rheumatoid arthritis(Fatigue will be assessed at baseline, and then 3 months after the omega3 supplementation)
- Effect of omega3 supplementation on sleep quality during rheumatoid arthrtis(Sleep quality during rheumatoid arthritis will be assessed at baseline and then 3 months after omega3 supplementation)
研究者
Selma Bouden
Assistant Doctor
Hopital Charles Nicolle