Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency

Phase 3

• Conditions: Vitamin D Deficiency; Rheumatoid Arthritis
• Interventions: Other: cholecalciferol versus placebo

• Registration Number: NCT02243800
• Lead Sponsor: University Hospital, Clermont-Ferrand

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).

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-18
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	cholecalciferol versus placebo	One group will receive the study treatment: cholecalciferol One group will receive placebo
cholecalciferol	cholecalciferol versus placebo	One group will receive the study treatment: cholecalciferol One group will receive placebo

Primary Outcome Measures

Name	Time	Method
The change in functional disability measured by the HAQ between the treated group and the placebo group.	at day 1

Secondary Outcome Measures

Name	Time	Method
The EULAR response criteria	at day 1
ACR response criteria	at day 1
The number of tender joints	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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France