NCT05345899

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 8, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

2.5 years

First QC Date

April 5, 2022

Last Update Submit

February 8, 2024

Conditions

Lupus or SLESpondyloarthritis

Outcome Measures

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

    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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (1)

chronic rheumatism

OTHER

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 plasmaOther: Evaluation of quality of life

Interventions

Evaluation of vitamin C level in plasmaDIAGNOSTIC_TEST

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

chronic rheumatism
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)

chronic rheumatism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, Alpes Maritimes, 06000, France

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, SystemicSpondylarthritis

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Central Study Contacts

Nathalie TIEULIE

CONTACT

04 92 03 90 19tieulie.n@chu-nice.fr

Sabiha ACHIOU

CONTACT

04 92 03 54 81achiou.s@chu-nice.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 26, 2022

Study Start

June 8, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)