Status:
COMPLETED
PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis
Lead Sponsor:
Christian Pagnoux
Conditions:
ANCA-associated Vasculitis
Granulomatosis With Polyangiitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 enrollm...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04280601
Start Date
August 1 2020
End Date
March 1 2023
Last Update
March 14 2023
Active Locations (1)
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1
Mount Sinai Hospital, Vasculitis clinic
Toronto, Canada