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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02243800
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : September 18, 2014
Last Update Posted : July 29, 2016
Sponsor:
Collaborators:
CRINEX Laboratory
BP 337 - 3 rue de Gentilly
92541 MONTROUGE Cedex FRANCE
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Vitamin D Deficiency Other: cholecalciferol versus placebo Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency
Study Start Date : November 2011
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. The change in functional disability measured by the HAQ between the treated group and the placebo group. [ Time Frame: at day 1 ]

Secondary Outcome Measures :
  1. The EULAR response criteria [ Time Frame: at day 1 ]
  2. ACR response criteria [ Time Frame: at day 1 ]
  3. The number of tender joints [ Time Frame: at day 1 ]
  4. The number of swollen joints [ Time Frame: at day 1 ]
  5. VAS pain [ Time Frame: at day 1 ]
  6. EVA activity [ Time Frame: at day 1 ]
  7. Parameters of inflammation [ Time Frame: at day 1 ]
  8. Asthenia collected by VAS and FACIT - tiredness [ Time Frame: at day 1 ]
  9. The impact of RA activity (RAID) [ Time Frame: at day 1 ]
  10. Quality of life (SF-36, EMIR, MOS, PASS) [ Time Frame: at day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243800


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
CRINEX Laboratory
BP 337 - 3 rue de Gentilly
92541 MONTROUGE Cedex FRANCE
Investigators
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Principal Investigator: Martin SOUBRIER University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02243800    
Other Study ID Numbers: CHU-0205
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Keywords provided by University Hospital, Clermont-Ferrand:
Vitamin D
Rheumatoid arthritis
Cholecalciferol
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Vitamin D Deficiency
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Bone Density Conservation Agents