Nutritional Strategies to Increase Nitric Oxide Signaling in Raynaud's Phenomenon (NivOSe)
Raynaud Phenomenon
About this trial
This is an interventional treatment trial for Raynaud Phenomenon focused on measuring l-citrullin, beetroot juice, Raynaud's phenomenon
Eligibility Criteria
Inclusion Criteria:
- 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
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
Sites / Locations
- Grenoble University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
L-citrulline
Beetroot juice
L-citrulline placebo
Denitrated beetroot juice
Six cycles will be conducted over two consecutive winters. One cycle will consist of two 2-week supplementation periods. A 7 days wash-out period will be imposed between treatment periods (placebo and treatment).
Six cycles will be conducted over two consecutive winters. One cycle will consist of two 2-week supplementation periods. A 7 days wash-out period will be imposed between treatment periods (placebo and treatment).
Six cycles will be conducted over two consecutive winters. One cycle will consist of two 2-week supplementation periods. A 7 days wash-out period will be imposed between treatment periods (placebo and treatment).
Six cycles will be conducted over two consecutive winters. One cycle will consist of two 2-week supplementation periods. A 7 days wash-out period will be imposed between treatment periods (placebo and treatment).