Back to resultsPRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis (PRAVDA)
Primary Purpose
ANCA-associated Vasculitis, Granulomatosis With Polyangiitis, Microscopic Polyangiitis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for ANCA-associated Vasculitis focused on measuring Vitamin D, ANCA, Vasculitis
Eligibility Criteria
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
Sites / Locations
- Mount Sinai Hospital, Vasculitis clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Low vitamin level at baseline
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Renal function (GFR)
Number of patients with progressive renal AAV-related disease (worsening GFR) in each study arm between enrollments and month 12
Cardiovascular events
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)
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)
Use of glucocorticoids (including cumulative dose) in each study arm between enrollment and month 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04280601
Brief Title
PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis
Acronym
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")
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christian Pagnoux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ANCA-associated Vasculitis, Granulomatosis With Polyangiitis, Microscopic Polyangiitis, Eosinophilic Granulomatosis With Polyangiitis
Keywords
Vitamin D, ANCA, Vasculitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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-months
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low vitamin level at baseline
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention 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-months
Primary Outcome Measure Information:
Title
Disease activity and disease relapse (using BVAS)
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Renal function (GFR)
Description
Number of patients with progressive renal AAV-related disease (worsening GFR) in each study arm between enrollments and month 12
Time Frame
12 Months
Title
Cardiovascular events
Description
Number of patients with cardiovascular events (IM, stroke) in each study arm between enrollments and month 12
Time Frame
12 Months
Title
Interstitial lung disease diagnosis or progression (imaging and PFT)
Description
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
Time Frame
12 Months
Title
Glucocorticoid use (and cumulative dose, mg)
Description
Use of glucocorticoids (including cumulative dose) in each study arm between enrollment and month 12
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Pagnoux, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital, Vasculitis clinic
City
Toronto
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.canvasc.ca
Description
Website of the Canadian vasculitis research network, listing ongoing studies and their status in Canada
Learn more about this trial
PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis
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