Lupus or SLEVitCRICNCT05345899
Evaluation of Plasma Vitamin C Levels in a Population of Chronic Rheumatism in Immuno-Rheumatology
A study testing Evaluation of vitamin C level in plasma and Evaluation of quality of life in people with Lupus or SLE and Spondyloarthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus or SLE, Spondyloarthritis
- What is being tested?
- Evaluation of vitamin C level in plasma and Evaluation of quality of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2022to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lupus or SLE, Spondyloarthritis
- Being tested
- Evaluation of vitamin C level in plasma, Evaluation of quality of life
- Medical subject headings
- Lupus Erythematosus, Systemic, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of vitamin C level in plasmaDiagnostic test
A protocol-specific blood test wil assess the vitamin C level in plasma
Evaluation of quality of lifeOther
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)
| Study group | Role | What they receive |
|---|---|---|
| chronic rheumatism | Other | Population of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain Receives: Diagnostic Test: Evaluation of vitamin C level in plasma; Other: Evaluation of quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at inclusion
Secondary outcomes (11)
Age of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Measured: at inclusion
Sexe of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Measured: at inclusion
Socio-professional category of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Measured: at inclusion
Type of disease of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Measured: at inclusion
Length of illness of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start8 Jun 2022
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus or SLEStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345899
- Sponsor's protocol ID
- 21-PP-09
- Acronym
- VitCRIC
- Status last verified
- Jun 2026
- First submitted
- 5 Apr 2022
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plasma Vitamin C Levels in a Population of Chronic Rheumatism in Immuno-Rheumatology
- ClinicalTrials.gov ID
- NCT05345899
- Acronym / sponsor ID
- VitCRIC / 21-PP-09
- Conditions
- Lupus or SLE, Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic rheumatism | Other | Diagnostic Test: Evaluation of vitamin C level in plasma, Other: Evaluation of quality of lifePopulation of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of vitamin C level in plasmaA protocol-specific blood test wil assess the vitamin C level in plasma | Diagnostic test | chronic rheumatism |
| Evaluation of quality of lifeSeveral 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) | Other | chronic rheumatism |
Primary outcome
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.
11 secondary outcomes
Age of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Time frame: at inclusion
Sexe of patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Time frame: at inclusion
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
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
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
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
Pain 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 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 by patients followed for chronic inflammatory rheumatism in remission or lupus in low activity, with chronic residual pain
Time frame: at inclusion
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Lupus or SLE
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
RecruitingPhase 1
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of vitamin C level in plasma and Evaluation of quality of life in people with Lupus or SLE and Spondyloarthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.