Evaluation of Plasma Vitamin C Levels in a Population of Chronic Rheumatism in Immuno-Rheumatology (VitCRIC)
Primary Purpose
Lupus or SLE, Spondyloarthritis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of vitamin C level in plasma
Evaluation of quality of life
Sponsored by
About this trial
This is an interventional diagnostic trial for Lupus or SLE
Eligibility Criteria
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 3 months,
- persistence of painful complaints not objectively explained by his RIC, with a score on the EVA pain upper to 2.
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.
Sites / Locations
- CHU de NiceRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
chronic rheumatism
Arm Description
Population of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Age of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Sexe of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Socio-professional category of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Type of disease of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Length of illness of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Type of disease's treatment for patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
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)
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).
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.
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.
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.
Full Information
NCT ID
NCT05345899
First Posted
April 5, 2022
Last Updated
July 26, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT05345899
Brief Title
Evaluation of Plasma Vitamin C Levels in a Population of Chronic Rheumatism in Immuno-Rheumatology
Acronym
VitCRIC
Official Title
Evaluation of Plasma Vitamin C Levels in a Population of Chronic Rheumatism in Immuno-Rheumatology
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
December 8, 2023 (Anticipated)
Study Completion Date
December 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus or SLE, Spondyloarthritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chronic rheumatism
Arm Type
Other
Arm Description
Population of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Intervention Type
Diagnostic Test
Intervention Name(s)
Evaluation of vitamin C level in plasma
Intervention Description
A protocol-specific blood test wil assess the vitamin C level in plasma
Intervention Type
Other
Intervention Name(s)
Evaluation of quality of life
Intervention Description
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 Outcome Measure Information:
Title
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
Description
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.
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Age of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Time Frame
at inclusion
Title
Sexe of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Time Frame
at inclusion
Title
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
Title
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
Title
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
Title
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
Title
Pain felt by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Description
Pain felt will be assessed with a visual and analog scale for pain which ranges from 0 (no pain) to 10 (maximum imaginable pain)
Time Frame
at inclusion
Title
Tiredness felt by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Description
Tiredness felt will be assessed with a visual and analog scale for tiredness which ranges from 0 (no tiredness) to 10 (extreme tiredness).
Time Frame
at inclusion
Title
Neuropatic pain felt by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Description
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.
Time Frame
at inclusion
Title
Quality of life of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Description
Quality of life will be assessed with the Short Form 12 (SF12) questionnaire.
Time Frame
at inclusion
Title
Anxiety and depression of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Description
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.
Time Frame
at inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 3 months,
persistence of painful complaints not objectively explained by his RIC, with a score on the EVA pain upper to 2.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie TIEULIE
Phone
04 92 03 90 19
Ext
+33
Email
tieulie.n@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sabiha ACHIOU
Phone
04 92 03 54 81
Ext
+33
Email
achiou.s@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
State/Province
Alpes Maritimes
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie THIEULIE
Phone
04 92 03 90 19
Ext
.33
Email
tieulie.n@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Nathalie TIEULIE
First Name & Middle Initial & Last Name & Degree
Véronique BREUIL
First Name & Middle Initial & Last Name & Degree
Stéphanie FERRERO
First Name & Middle Initial & Last Name & Degree
Marion LOUVOIS
First Name & Middle Initial & Last Name & Degree
Yacine ALLAM
First Name & Middle Initial & Last Name & Degree
Jérémy GENOVESE
First Name & Middle Initial & Last Name & Degree
Viviane QUEYREL
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Plasma Vitamin C Levels in a Population of Chronic Rheumatism in Immuno-Rheumatology
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