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

Rheumatoid Arthritis Clinical Trial

— SCORPION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02243800
• Other study ID #: CHU-0205
• Status: Recruiting
• Phase: Phase 3
• First received: September 16, 2014
• Last updated: July 28, 2016
• Start date: November 2011
• Est. completion date: August 2016

Study information

• Verified date: July 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Vitamin D Deficiency

Intervention

Other:
• cholecalciferol versus placebo

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	92541 MONTROUGE Cedex FRANCE, BP 337 - 3 rue de Gentilly, CRINEX Laboratory

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in functional disability measured by the HAQ between the treated group and the placebo group.		at day 1	Yes
Secondary	The EULAR response criteria		at day 1	Yes
Secondary	ACR response criteria		at day 1	Yes
Secondary	The number of tender joints		at day 1	Yes
Secondary	The number of swollen joints		at day 1	Yes
Secondary	VAS pain		at day 1	Yes
Secondary	EVA activity		at day 1	Yes
Secondary	Parameters of inflammation		at day 1	Yes
Secondary	Asthenia collected by VAS and FACIT - tiredness		at day 1	Yes
Secondary	The impact of RA activity (RAID)		at day 1	Yes
Secondary	Quality of life (SF-36, EMIR, MOS, PASS)		at day 1	Yes