NCT03749577

Nutritional Strategies to Increase Nitric Oxide Signaling in Raynaud's Phenomenon

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Raynaud Phenomenon

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L-citrulline	L-citrulline 9g per day (capsule, per os) during 14 days;
DIETARY_SUPPLEMENT	Beetroot juice	Concentrated 70 ml beetroot juice bottles containing 6.45 mmol of nitrates
DIETARY_SUPPLEMENT	L-citrulline placebo	L-citrulline placebo (maltodextrin) 9g per day (capsule, per os) during 14 days
DIETARY_SUPPLEMENT	Denitrated beetroot juice	Concentrated 70 ml nitrate-depleted beetroot juice

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-04-30
• Completion: 2022-06-30
• First posted: 2018-11-21
• Last updated: 2021-05-14

Locations

1 site across 1 country: France