Raynaud Phenomenon Clinical Trial
— NivOSeOfficial title:
Nutritional Strategies to Increase Nitric Oxide Signaling in Raynaud's Phenomenon
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 30, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - BMI > 18 - Active Raynaud's Phenomenon characterized by a clinical history of Raynaud's 1. Primary RP or secondary to limited (LSSc), limited or diffuse cutaneous scleroderma (lcSSc or dcSSc) according to the criteria of Leroy and Medsger. 2. 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Grenoble University Hospital | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | University Hospital, Rouen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Raynaud Condition Score | 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. | first winter: inclusion visit week 2, week 7, week 13, week 19; second winter: inclusion visit week 2,week 7, week 13, week 19 | |
Primary | Frequency of RP | number of RP attacks during treatment, as compared to placebo | 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) | |
Primary | Change in cumulative attack duration | 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. | first winter: inclusion visit week 2, week 7, week 13, week 19; second winter: inclusion visit week 2,week 7, week 13, week 19 | |
Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 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.
It will be assessed through adverse events collected in the daily dairies cards. |
first winter: week 2, 4, 5, 7, 13, 19; second winter: week 2, 4, 5, 7, 13, 19 | |
Secondary | Plasma concentration of L-arginine/ADMA ratio | It will be quantified and compared under the 4 conditions. | first winter: week 2, 4, 5, 7; second winter: week 2, 4, 5, 7 | |
Secondary | Plasma concentration of nitrites | It will be quantified and compared under the 4 conditions. | first winter: week 2, 4, 5, 7; second winter: week 2, 4, 5, 7 | |
Secondary | Plasma concentration of L-arginine | It will be quantified and compared under the 4 conditions. | first winter: week 2, 4, 5, 7; second winter: week 2, 4, 5, 7 | |
Secondary | Urinary GMPc | It will be quantified and compared under the 4 conditions. | first winter: week 2, 4, 5, 7; second winter: week 2, 4, 5, 7 |
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