NCT04280601

PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis

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")

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Christian Pagnoux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ANCA-associated Vasculitis
• Granulomatosis With Polyangiitis
• Microscopic Polyangiitis
• Eosinophilic Granulomatosis With Polyangiitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2020-02-21
• Last updated: 2023-03-14

Locations

1 site across 1 country: Canada