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Clinical Trials/NCT05345899
NCT05345899CompletedNot Applicable

Evaluation of Plasma Vitamin C Levels in a Population of Chronic Rheumatism in Immuno-Rheumatology

Centre Hospitalier Universitaire de Nice1 site in 1 country107 target enrollmentStarted: June 8, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
107
Locations
1
Primary Endpoint
Describe prevalence of hypovitaminose C (ascorbemia below 23 µmol/L) in a population of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

Study Overview

Brief Summary

Scurvy is an almost forgotten carential pathology, caused by a deep vitamin C (or ascorbic acid) deficiency, a priori exceptional in industrialized countries. According to the French National Authority for Health standards, hypovitaminosis C is defined as a plasma vitamin C level of less than 23 μmol/L. This deficiency would affect 5 to 10% of the general population in industrialized countries and from 17% (clinical scurvy) to 47% (biological hypovitaminosis C) of vulnerable populations (malnutrition, hospitalized patients...). Vitamin C is essential for collagen synthesis. It plays a cofactor role in the synthesis of catecholamines precursors and takes action in synthesis of certain amino acids.

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •patient over 18 years-old,
  • •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

  • •pregnant or nursing patient,
  • •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.

Arms & Interventions

chronic rheumatism

Other

Population of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

Intervention: Evaluation of vitamin C level in plasma (Diagnostic Test)

chronic rheumatism

Other

Population of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

Intervention: Evaluation of quality of life (Other)

Outcomes

Primary Outcomes

Describe prevalence of hypovitaminose C (ascorbemia below 23 µmol/L) in a population of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

Time Frame: at inclusion

Among patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain and included in this study, the prevalence of hypovitaminosis C will be the proportion of patients with ascorbemia below 23 μmol/L measured at inclusion. Plasma ascorbemia will be measured using HPLC fluorimetric detection, using a Chromsystems kit.

Secondary Outcomes

  • Age of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain(at inclusion)
  • Type of disease of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain(at inclusion)
  • Length of illness of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain(at inclusion)
  • Type of disease's treatment for patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain(at inclusion)
  • Socio-professional category of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain(at inclusion)
  • Pain felt by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain(at inclusion)
  • Neuropatic pain felt by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain(at inclusion)
  • Quality of life of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain(at inclusion)
  • Sexe of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain(at inclusion)
  • Tiredness felt by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain(at inclusion)
  • Anxiety and depression of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain(at inclusion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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