PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis (PRAVDA)

Christian Pagnoux

Status: Completed

Conditions: Granulomatosis With Polyangiitis; ANCA-associated Vasculitis; Eosinophilic Granulomatosis With Polyangiitis; Microscopic Polyangiitis

Treatments: Dietary Supplement: vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT04280601

19-0039-E

Details and patient eligibility

About

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).

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Low vitamin level at baseline

Other group

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.

Treatment:

Dietary Supplement: vitamin D