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临床试验/NCT05345899
NCT05345899已完成不适用

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

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2022年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
1
主要终点
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

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

chronic rheumatism

Other

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

干预措施: 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

干预措施: Evaluation of quality of life (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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