Status:
UNKNOWN
Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
CRINEX Laboratory
BP 337 - 3 rue de Gentilly
Conditions:
Rheumatoid Arthritis
Vitamin D Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 syno...
Detailed Description
This is an interventional, multicenter (13 rheumatology units) randomized, double-blinded study against placebo, lasting 24 weeks. The main objective is to demonstrate that treatment with cholecalcife...
Eligibility Criteria
Inclusion
- \- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT02243800
Start Date
November 1 2011
End Date
August 1 2016
Last Update
July 29 2016
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003