Clinical trial NCT04280601: PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis
Official title: A Local Interventional Study in a Cohort of Patients With GPA, MPA and EGPA (PART 2 of "Vitamin D Status in ANCA-associated Vasculitis: Analysis of RDCRN-VCRC and Local Clinic Cohorts of Patients With GPA, MPA and EGPA")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ANCA-associated Vasculitis
Granulomatosis With Polyangiitis
Microscopic Polyangiitis
Eosinophilic Granulomatosis With Polyangiitis
Keywords: Vitamin D
ANCA
Vasculitis
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease activity and disease relapse (using BVAS)
timeFrame: 12 months
Secondary outcomes:
measure: Renal function (GFR)
timeFrame: 12 Months
measure: Cardiovascular events
timeFrame: 12 Months
measure: Interstitial lung disease diagnosis or progression (imaging and PFT)
timeFrame: 12 Months
measure: Glucocorticoid use (and cumulative dose, mg)
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital, Vasculitis clinic
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Christian Pagnoux, MD
role: PRINCIPAL_INVESTIGATOR
References: