PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis

Brief Title

PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis

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")

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 Type

Interventional

Primary Outcome

Disease activity and disease relapse (using BVAS)

Secondary Outcome

 Renal function (GFR)

Condition

ANCA-associated Vasculitis

Intervention

vitamin D

Study Arms / Comparison Groups

 Low vitamin level at baseline

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Dietary Supplement

Estimated Enrollment

102

Start Date

August 1, 2020

Completion Date

March 1, 2023

Primary Completion Date

March 1, 2023

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christian Pagnoux, MD, , 

Location Countries

Canada

Location Countries

Canada

NCT ID

NCT04280601

Organization ID

19-0039-E

Responsible Party

Sponsor-Investigator

Study Sponsor

Christian Pagnoux

Study Sponsor

Christian Pagnoux, MD, Principal Investigator, MOUNT SINAI HOSPITAL

Verification Date

March 2023