CompletedNot Applicable

PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis

Canada102 participantsStarted 2020-08-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Disease activity and disease relapse (using BVAS)

Timeframe: 12 months

Trial details

NCT IDNCT04280601

SponsorChristian Pagnoux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-01

View on ClinicalTrials.gov More ANCA-associated Vasculitis trials