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

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 Overview

• Status: Recruiting
• Conditions: Spondyloarthritis; Lupus or SLE
• Intervention / Treatment: Diagnostic test: Evaluation of vitamin C level in plasma; Other: Evaluation of quality of life

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie TIEULIE; Phone Number: +33 04 92 03 90 19; Email: tieulie.n@chu-nice.fr
• Study Contact Backup: Name: Sabiha ACHIOU; Phone Number: +33 04 92 03 54 81; Email: achiou.s@chu-nice.fr

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06000
      • Recruiting
      • CHU de Nice
      • Contact: Nathalie THIEULIE; Phone Number: .33 04 92 03 90 19; Email: tieulie.n@chu-nice.fr
      • Principal Investigator: Nathalie TIEULIE
      • Sub-Investigator: Véronique BREUIL
      • Sub-Investigator: Stéphanie FERRERO
      • Sub-Investigator: Marion LOUVOIS
      • Sub-Investigator: Yacine ALLAM
      • Sub-Investigator: Jérémy GENOVESE
      • Sub-Investigator: Viviane QUEYREL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Diagnostic test: Evaluation of vitamin C level in plasma; A protocol-specific blood test wil assess the vitamin C level in plasma; Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age 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
Socio-professional category 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
Pain felt by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain	Pain felt will be assessed with a visual and analog scale for pain which ranges from 0 (no pain) to 10 (maximum imaginable pain)	at inclusion
Tiredness felt by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain	Tiredness felt will be assessed with a visual and analog scale for tiredness which ranges from 0 (no tiredness) to 10 (extreme tiredness).	at inclusion
Neuropatic pain felt by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain	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.	at inclusion
Quality of life of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain	Quality of life will be assessed with the Short Form 12 (SF12) questionnaire.	at inclusion
Anxiety and depression of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain	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.	at inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Rheumatic Diseases; Spondylitis; Spondylarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: 21-PP-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No