This prospective study will assess if 12 months of vitamin D3 (cholecalciferol) supplementation, in patients with AAV (GPA, MPA, and EGPA) who have deficient or insufficient 25(OH)D3 status at enrollment, correlates with improved disease activity and/or lower frequency of relapse (compared to historical data and a previously conducted cross sectional study (part I) that assessed vitamin D status in a cohort of similar patients).
1. Subject cohorts: Patients with a diagnosis of AAV from the MSH Rheumatology clinic in a cohort of consecutive patients over a 3 month recruitment period. 2. Study Design, Data Collection: Patients with insufficient and/or deficient vitamin D status at study enrolment will be instructed to take 12 months of vitamin D3 (cholecalciferol) supplementation (1000 IU for those not on vitamin D, or to increase the dose up to 2000 IU per day for those already on vitamin D) vs. those with sufficient status who will be observed for 12-months. 3. Study Duration: 12 months. 4. Study Endpoints: Vitamin D status vs. disease activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Patients with insufficient and/or deficient vitamin D status (\<75 nmol/L) at study enrolment will be instructed to take a 12-month supply of vitamin D3 supplementation (to a maximum of 2,000 IU/day) vs. those with sufficient status will be observed for 12-months
Mount Sinai Hospital, Vasculitis clinic
Toronto, Canada
Disease activity and disease relapse (using BVAS)
Number of patients with active disease (BVAS score) or disease relapse (new item on the BVAS, in patients previously in remission) between enrollment and month 12, according to the study arm intervention (normal baseline vitamin D level vs. low baseline level and asked to increase vitamin D intake)
Time frame: 12 months
Renal function (GFR)
Number of patients with progressive renal AAV-related disease (worsening GFR) in each study arm between enrollments and month 12
Time frame: 12 Months
Cardiovascular events
Number of patients with cardiovascular events (IM, stroke) in each study arm between enrollments and month 12
Time frame: 12 Months
Interstitial lung disease diagnosis or progression (imaging and PFT)
Number of patients with new diagnosis of ILD or worsening of ILD in each study arm (based on clinical, and either imaging and/or PFT findings) between enrollments and month 12
Time frame: 12 Months
Glucocorticoid use (and cumulative dose, mg)
Use of glucocorticoids (including cumulative dose) in each study arm between enrollment and month 12
Time frame: 12 months
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