PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis (PRAVDA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04280601|
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|ANCA-associated Vasculitis Granulomatosis With Polyangiitis Microscopic Polyangiitis Eosinophilic Granulomatosis With Polyangiitis||Dietary Supplement: vitamin D||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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-months|
|Masking:||None (Open Label)|
|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 :||August 1, 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||December 2021|
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
- Disease activity and disease relapse (using BVAS) [ Time Frame: 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)
- Renal function (GFR) [ Time Frame: 12 Months ]Number of patients with progressive renal AAV-related disease (worsening GFR) in each study arm between enrollments and month 12
- Cardiovascular events [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 12 months ]Use of glucocorticoids (including cumulative dose) in each study arm between enrollment and month 12
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280601
|Contact: Christian Pagnoux, MD||416 586 4800 ext email@example.com|
|Contact: Irena Doubelt, MD||416 586 4800 ext 8549||Irena.Doubelt@one-mail.on.ca|
|Mount Sinai Hospital, Vasculitis clinic||Recruiting|
|Contact: Christian Pagnoux, MD firstname.lastname@example.org|
|Principal Investigator:||Christian Pagnoux, MD||MOUNT SINAI HOSPITAL|