NCT02243800

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P25-P50 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

4.8 years

First QC Date

September 16, 2014

Last Update Submit

July 28, 2016

Conditions

Rheumatoid ArthritisVitamin D Deficiency

Keywords

Vitamin DRheumatoid arthritisCholecalciferol

Outcome Measures

Primary Outcomes (1)

  • The change in functional disability measured by the HAQ between the treated group and the placebo group.

    at day 1

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

cholecalciferol

EXPERIMENTAL

One group will receive the study treatment: cholecalciferol One group will receive placebo

Other: cholecalciferol versus placebo

placebo

PLACEBO COMPARATOR

One group will receive the study treatment: cholecalciferol One group will receive placebo

Other: cholecalciferol versus placebo

Interventions

cholecalciferol versus placeboOTHER
cholecalciferolplacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidVitamin D Deficiency

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Martin SOUBRIER

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 18, 2014

Study Start

November 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

FR(1)