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

NCT03749577 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-14

No results posted yet for this study

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.

Conditions

  • Raynaud Phenomenon

Interventions

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

Sponsors & Collaborators

  • University Hospital, Rouen

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean-Luc Cracowski, MD · Grenoble University Hospital, Clinical Pharmacology Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-04-30
Completion
2022-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03749577 on ClinicalTrials.gov