Clinical trial NCT02243800: Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency
Official title: Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Vitamin D Deficiency
Keywords: Vitamin D
Rheumatoid arthritis
Cholecalciferol
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: CRINEX Laboratory
name: BP 337 - 3 rue de Gentilly
name: 92541 MONTROUGE Cedex FRANCE
First posted: 2014-09-18
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 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.

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 cholecalciferol improves functional disability (HAQ) in patients with RA not in remission (DAS28 VS\> 2.6 and the investigator does not think to change the treatment in the 3 months after enrolment) and vitamin D deficiency (vitamin D \<30 ng / ml). Secondary objectives will be to examine whether there is a decrease in disease activity (tender joint count, swollen joint count, VAS, EVA activity, ESR, CRP, EULAR criteria, ACR), a decrease in fatigue (FACIT EVA - fatigue), improved quality of life (SF36, EMIR, PASS, MOS) and the impact of RA (RAID).

Eligibility criteria: 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The change in functional disability measured by the HAQ between the treated group and the placebo group.
timeFrame: at day 1
Secondary outcomes:
measure: The EULAR response criteria
timeFrame: at day 1
measure: ACR response criteria
timeFrame: at day 1
measure: The number of tender joints
timeFrame: at day 1
measure: The number of swollen joints
timeFrame: at day 1
measure: VAS pain
timeFrame: at day 1
measure: EVA activity
timeFrame: at day 1
measure: Parameters of inflammation
timeFrame: at day 1
measure: Asthenia collected by VAS and FACIT - tiredness
timeFrame: at day 1
measure: The impact of RA activity (RAID)
timeFrame: at day 1
measure: Quality of life (SF-36, EMIR, MOS, PASS)
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martin SOUBRIER
role: PRINCIPAL_INVESTIGATOR
References: