ANCA-associated Vasculitis, Eosinophilic Granulomatosis With Polyangiitis, Granulomatosis With Polyangiitis, Microscopic Polyangiitis
Conditions
Keywords
Vitamin D, ANCA, Vasculitis
Brief summary
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).
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTvitamin D
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
Sponsors
Christian Pagnoux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at least 18 years of age, women and men * Followed at the Mount Sinai Hospital, Vasculitis clinic, Toronto * With a diagnosis of AAV (GPA, MPA or EGPA) satisfying the modified American College of Rheumatology 1990 classification criteria and/or the revised 2012 Chapel Hill nomenclature definition.
Exclusion criteria
* Current or history of hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D, Williams syndrome, other autoimmune, chronic inflammatory or infectious conditions, malabsorptive disorders, cancer, type 1 diabetes, liver disease * Current or planned pregnancy within the next year. * Intolerance, allergy to oral vitamin D, and/or contra-indication to take oral vitamin D
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity and disease relapse (using BVAS) | 12 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal function (GFR) | 12 Months | Number of patients with progressive renal AAV-related disease (worsening GFR) in each study arm between enrollments and month 12 |
| Cardiovascular events | 12 Months | Number of patients with cardiovascular events (IM, stroke) in each study arm between enrollments and month 12 |
| Interstitial lung disease diagnosis or progression (imaging and PFT) | 12 Months | 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 |
| Glucocorticoid use (and cumulative dose, mg) | 12 months | Use of glucocorticoids (including cumulative dose) in each study arm between enrollment and month 12 |
Countries
Canada
Outcome results
None listed