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NCT Number: NCT05345899

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

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.

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Key information

Conditions

Lupus or SLE Arthritis Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylitis Spondyloarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evaluation of vitamin C level in plasma

Diagnostic Test

A protocol-specific blood test wil assess the vitamin C level in plasma

Evaluation of quality of life

Other

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)

Primary outcomes

  1. 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

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

    Time frame: at inclusion

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

    Time frame: at inclusion

  3. Socio-professional category of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

    Time frame: at inclusion

  4. Type of disease of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

    Time frame: at inclusion

  5. Length of illness of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

    Time frame: at inclusion

  6. Type of disease's treatment for patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

    Time frame: at inclusion

  7. Pain felt by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

    Time frame: at inclusion

    Pain felt will be assessed with a visual and analog scale for pain which ranges from 0 (no pain) to 10 (maximum imaginable pain)

  8. Tiredness felt by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

    Time frame: at inclusion

    Tiredness felt will be assessed with a visual and analog scale for tiredness which ranges from 0 (no tiredness) to 10 (extreme tiredness).

  9. Neuropatic pain felt by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

    Time frame: at inclusion

    Neuropatic pain felt will be assessed with the neuropatic pain 4 (DN4) questionnaire, which ranges from 0 to 10. A score greater than 4 indicates a positive test.

  10. Quality of life of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

    Time frame: at inclusion

    Quality of life will be assessed with the Short Form 12 (SF12) questionnaire.

  11. Anxiety and depression of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain

    Time frame: at inclusion

    Anxiety and depression will be assessed with the Hospital Anxiety and Depression (HAD) scale, splited in 2 scores which ranges from 0 to 21. A score less than 7 indicates a lack of symtomatology, a score between 8 and 10 indicates doubtful symptomatology and a score higher than 11 indicates a sure symptomatology.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: VitCRIC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 26, 2022
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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