Nutritional Strategies to Increase Nitric Oxide Signaling in Raynaud's Phenomenon
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in cumulative attack duration
研究概览
简要总结
The investigators aim at comparing the efficacy of a 2 weeks supplementation by L-citrulline or beetroot juice to L-citrulline placebo or denitrated beetroot juice respectively on Raynaud's phenomenon severity. Raynaud's phenomenon severity will be assessed through the Raynaud Condition Score, daily frequency of attacks or cumulative attack duration (expressed as min) daily collected by patients in a diary. Each Volunteer will choose his own main outcome among these 3 criteria.
详细描述
Raynaud's phenomenon (RP) is a clinical condition that follows an exaggerated vasoconstriction of extremities in response to a cold or emotional stress. Microvascular dysfunction and alteration of the endothelial NO-dependent vasodilatation pathway through NO synthases (NOS) represents one of the main mechanisms.
A pharmacological treatment in RP is proposed to patients when conservative measures are not efficient enough to control the symptoms: calcium channel blockers remains the first line, phosphodiesterase type 5 inhibitors as a second line treatment, while intravenous iloprost remains restricted to patients with digital ischaemia. Vasodilator therapies are commonly associated with side effects due to the non-specific systemic vasodilation that often result in permanent discontinuation. Many patients prefer complementary and alternative therapies, but none has proven its efficacy. Therefore, there is still room for improvement in the treatment of RP, and research is needed in this area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 18
- •Active Raynaud's Phenomenon characterized by a clinical history of Raynaud's
- •Primary RP or secondary to limited (LSSc), limited or diffuse cutaneous scleroderma (lcSSc or dcSSc) according to the criteria of Leroy and Medsger.
- •At least 1 RP attacks per week and a specific finger patient picture in RP attack (assessed over the 2 weeks preceding inclusion)
- •Stable disease over the previous two months (i.e. recent diagnosis of SSc will be excluded)
- •Patients insured by a social security scheme or beneficiaries of such a scheme
- •Patients who have dated and signed the informed consent form
排除标准
- •Uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled angina
- •Haemodynamic instability
- •Pregnancy (or considering pregnancy in next 4 months) or breast feeding
- •Subject in an exclusion period from another study,
- •Subject under administrative or judicial supervision
- •Subject not able to be contacted in case of emergency
结局指标
主要结局
Change in cumulative attack duration
时间窗: first winter: inclusion visit week 2, week 7, week 13, week 19; second winter: inclusion visit week 2,week 7, week 13, week 19
Mean duration of Raynaud's attacks for a time period was calculated as sum of recorded durations of attacks in the time period divided by total number of attacks in the time period where duration was recorded.
Frequency of RP
时间窗: 7 days (An attack is defined as an episode of pallor or cyanosis (with or without pain,tingling or numbness). The number of attacks is self-reported every day and averaged over 7-day periods)
number of RP attacks during treatment, as compared to placebo
Change in Raynaud Condition Score
时间窗: first winter: inclusion visit week 2, week 7, week 13, week 19; second winter: inclusion visit week 2,week 7, week 13, week 19
Change from baseline in the Raynaud's Condition score (RCS). RCS is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon every day and impact of Raynaud's alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty.
次要结局
- Plasma concentration of L-arginine(first winter: week 2, 4, 5, 7; second winter: week 2, 4, 5, 7)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](first winter: week 2, 4, 5, 7, 13, 19; second winter: week 2, 4, 5, 7, 13, 19)
- Plasma concentration of L-arginine/ADMA ratio(first winter: week 2, 4, 5, 7; second winter: week 2, 4, 5, 7)
- Urinary GMPc(first winter: week 2, 4, 5, 7; second winter: week 2, 4, 5, 7)
- Plasma concentration of nitrites(first winter: week 2, 4, 5, 7; second winter: week 2, 4, 5, 7)