PRAVDA: PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis

Sponsor

Christian Pagnoux (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04280601

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
ANCA-associated Vasculitis Granulomatosis With Polyangiitis Microscopic Polyangiitis Eosinophilic Granulomatosis With Polyangiitis	Dietary Supplement: vitamin D	N/A

Detailed Description

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.
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.
Study Duration: 12 months.
Study Endpoints: Vitamin D status vs. disease activity.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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-monthsPatients 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

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")

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Low vitamin level at baseline 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.	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

Arm

Intervention/Treatment

Other: Low vitamin level at baseline

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.

Dietary Supplement: vitamin D

Outcome Measures

Primary Outcome Measures

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

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
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
Glucocorticoid use (and cumulative dose, mg) [12 months]
Use of glucocorticoids (including cumulative dose) in each study arm between enrollment and month 12

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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