PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis

Not Applicable

Completed

• Conditions: Granulomatosis With Polyangiitis; Microscopic Polyangiitis; ANCA-associated Vasculitis; Eosinophilic Granulomatosis With Polyangiitis
• Interventions: Dietary Supplement: vitamin D

• Registration Number: NCT04280601
• Lead Sponsor: Christian Pagnoux

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.

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Study Start: 2020-08-01
• Status Verified: 2023-03
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low vitamin level at baseline	vitamin D	At specific time points we will measure vitamin D status (baseline and 12-months) and re-enforcing vitamin D supplementation in those with insufficient or deficient vitamin D levels. More specifically, we will ask patients with insufficient or deficient vitamin D levels at enrollment to increase vitamin D intake by 1,000 IU units (to a maximum of 2,000 IU if the patient is already on vitamin D supplementation) for the 12 month period.

Primary Outcome Measures

Name	Time	Method
Disease activity and disease relapse (using BVAS)	12 months	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)

Secondary Outcome Measures

Name	Time	Method
Interstitial lung disease diagnosis or progression (imaging and PFT)	12 Months	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
Renal function (GFR)	12 Months	Number of patients with progressive renal AAV-related disease (worsening GFR) in each study arm between enrollments and month 12
Cardiovascular events	12 Months	Number of patients with cardiovascular events (IM, stroke) in each study arm between enrollments and month 12
Glucocorticoid use (and cumulative dose, mg)	12 months	Use of glucocorticoids (including cumulative dose) in each study arm between enrollment and month 12

Trial Locations

Locations (1)

Mount Sinai Hospital, Vasculitis clinic; 🇨🇦 Toronto, Canada