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

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Vitamin D Deficiency
• Intervention / Treatment: Other: cholecalciferol versus placebo

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 Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cholecalciferol; One group will receive the study treatment: cholecalciferol One group will receive placebo	Other: cholecalciferol versus placebo
Placebo Comparator: placebo; One group will receive the study treatment: cholecalciferol One group will receive placebo	Other: cholecalciferol versus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change in functional disability measured by the HAQ between the treated group and the placebo group.	at day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: CRINEX Laboratory; BP 337 - 3 rue de Gentilly; 92541 MONTROUGE Cedex FRANCE
• Investigators: Principal Investigator: Martin SOUBRIER, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 18, 2014

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Vitamin D; Rheumatoid arthritis; Cholecalciferol
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Nutrition Disorders; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Arthritis; Arthritis, Rheumatoid; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: CHU-0205