Status:
UNKNOWN
Nutritional Strategies to Increase Nitric Oxide Signaling in Raynaud's Phenomenon
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
University Hospital, Rouen
Conditions:
Raynaud Phenomenon
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03749577
Start Date
October 1 2020
End Date
June 30 2022
Last Update
May 14 2021
Active Locations (1)
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1
Grenoble University Hospital
Grenoble, France, 38000