Informations générales (source: ClinicalTrials.gov)
Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency (SCORPION)
Interventional
Phase 3
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
novembre 2011
août 2016
29 juin 2024
Vitamin D plays a key role in the regulation of calcium metabolism and bone physiology
and also presents immunomodulatory effects. In contrast to healthy individuals,
macrophages and synoviocytes synovium of patients with rheumatoid arthritis (RA) have
receptors for vitamin D. In vitro, 1,25 Vitamin D inhibits T cell proliferation and
cytokine synthesis and decreases pro-inflammatory process. There is an inverse
relationship, at least in some epidemiological studies, between the circulating levels of
25OH vitamin D and the occurrence and / or activity of RA. The hypothesis of our study is
that natural vitamin D supplementation in patients with RA and a vitamin D deficiency
(vitamin D <30 ng / mL) improves functional disability.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients with RA (ACR 1987) not in remission (DAS28> 2.6) in whom no change in
treatment is considered by the investigator for at least 3 months, DMARD stable RA
for at least 3 months and lack of infiltration in the last 2 months
- Serum 25-OH vitamin D <30 ng / ml
- Patients with RA (ACR 1987) not in remission (DAS28> 2.6) in whom no change in
treatment is considered by the investigator for at least 3 months, DMARD stable RA
for at least 3 months and lack of infiltration in the last 2 months
- Serum 25-OH vitamin D <30 ng / ml
- Arthritis resulting in class IV functional disability (according to the ACR
criteria)
- Hypercalcemia (serum calcium> 2.6 mmol/L) and/or known hypercalciuria (calcium
excretion> 4 mg / kg / day), history of renal colic, thiazideic therapy.
- Known hypersensitivity to vitamin D
- Patient refused to sign the consent form, pregnant or nursing women, patients minor,
major patients under protection of the Act