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| Name | Class |
|---|---|
| CRINEX Laboratory | UNKNOWN |
| BP 337 - 3 rue de Gentilly | UNKNOWN |
| 92541 MONTROUGE Cedex FRANCE | UNKNOWN |
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cholecalciferol | Experimental | One group will receive the study treatment: cholecalciferol One group will receive placebo |
|
| placebo | Placebo Comparator | One group will receive the study treatment: cholecalciferol One group will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol versus placebo | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in functional disability measured by the HAQ between the treated group and the placebo group. | at day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| The EULAR response criteria | at day 1 | |
| ACR response criteria | at day 1 | |
| The number of tender joints |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Martin SOUBRIER | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
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| at day 1 |
| The number of swollen joints | at day 1 |
| VAS pain | at day 1 |
| EVA activity | at day 1 |
| Parameters of inflammation | at day 1 |
| Asthenia collected by VAS and FACIT - tiredness | at day 1 |
| The impact of RA activity (RAID) | at day 1 |
| Quality of life (SF-36, EMIR, MOS, PASS) | at day 1 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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