Microscopic Polyangiitis Clinical Trial
— PRAVDAOfficial 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")
NCT number | NCT04280601 |
Other study ID # | 19-0039-E |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2020 |
Est. completion date | March 1, 2023 |
Verified date | March 2023 |
Source | Mount Sinai Hospital, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 102 |
Est. completion date | March 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital, Vasculitis clinic | Toronto |
Lead Sponsor | Collaborator |
---|---|
Christian Pagnoux |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 12 months | |
Secondary | Renal function (GFR) | Number of patients with progressive renal AAV-related disease (worsening GFR) in each study arm between enrollments and month 12 | 12 Months | |
Secondary | Cardiovascular events | Number of patients with cardiovascular events (IM, stroke) in each study arm between enrollments and month 12 | 12 Months | |
Secondary | 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 | 12 Months | |
Secondary | Glucocorticoid use (and cumulative dose, mg) | Use of glucocorticoids (including cumulative dose) in each study arm between enrollment and month 12 | 12 months |
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