PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis

Microscopic Polyangiitis Clinical Trial

— PRAVDA  

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")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280601
• Other study ID #: 19-0039-E
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• ANCA-associated Vasculitis
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Churg-Strauss Syndrome
• Eosinophilic Granulomatosis With Polyangiitis
• Granulomatosis With Polyangiitis
• Microscopic Polyangiitis
• Systemic Vasculitis
• Vasculitis

Intervention

Dietary Supplement:
• vitamin 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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital, Vasculitis clinic	Toronto

Sponsors (1)

Lead Sponsor	Collaborator
Christian Pagnoux

Country where clinical trial is conducted

Canada, 

Outcome

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

External Links

•   Website of the Canadian vasculitis research network, listing ongoing studies and their status in Canada