Evaluation of Plasma Vitamin C Levels in a Population of Chronic Rheumatism in Immuno-Rheumatology
NCT ID: NCT05345899
Last Updated: 2024-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2022-06-08
2024-12-31
Brief Summary
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In rheumatology, pain is a recurring reason for consultation. In a context of treated chronic inflammatory rheumatism (RIC), while most of patients seem in remission or in reduced activity of their disease, all real-life studies show that 30 to 40% of them complain of residual pain, 70% of chronic fatigue and 20-25% of symptoms similar to secondary fibromyalgia. Currently, authors suggest the interest of vitamin C analgesic properties, especially in musculoskeletal pain, due to the role of ascorbic acid in neurotransmitters. Vitamin C would act as a cofactor for a family of biosynthetic and regulatory metalloenzymes. Thus, the authors suggest the potential of vitamin C in an analgesic mechanism involving the biosynthesis of opioid peptides.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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chronic rheumatism
Population of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Evaluation of vitamin C level in plasma
A protocol-specific blood test wil assess the vitamin C level in plasma
Evaluation of quality of life
Several questionnaire will be completed by patients to evaluate quality of life: Analog and visual scale (EVA) pain, Neuropathic pain (DN) 4 questionnaire, EVA fatigue, Short Form (SF) 12 questionnaire and Hospital Anxiety and Depression scale (HAD questionnaire)
Interventions
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Evaluation of vitamin C level in plasma
A protocol-specific blood test wil assess the vitamin C level in plasma
Evaluation of quality of life
Several questionnaire will be completed by patients to evaluate quality of life: Analog and visual scale (EVA) pain, Neuropathic pain (DN) 4 questionnaire, EVA fatigue, Short Form (SF) 12 questionnaire and Hospital Anxiety and Depression scale (HAD questionnaire)
Eligibility Criteria
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Inclusion Criteria
* followed for chronic inflammatory rheumatism (RIC): spondylo-arthritis (including spondylitis and psoriatic rheumatism) and lupus,
* with RIC in remission or low activity definec according to the following criteria: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) criteria and Bath Ankylosing Spondylitis Fonctional Index (BASFI) questionnaire for spondylitis and psoriatic rheumatism, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K score for lupus,
* having given written consent after written and oral information,
* member of the social security system,
* basic treatment for the disease not modified for at least 6 months, without modification at baseline
* persistence of painful complaints not objectively explained by his RIC.
Exclusion Criteria
* patient protected by law or under guardianship or curatorship, or not able to participate in a clinical trial under L.1121-16 article of French Public Health Regulations,
* patient participating in or having participated in another drug clinical trial in the month prior to inclusion.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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CHU de Nice
Nice, Alpes Maritimes, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21-PP-09
Identifier Type: -
Identifier Source: org_study_id
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