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NCT Number: NCT04280601

PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis

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).

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Key information

Conditions

ANCA-associated Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Churg-Strauss Syndrome Eosinophilic Granulomatosis With Polyangiitis Granuloma Granulomatosis With Polyangiitis Hemic and Lymphatic Diseases Immune System Diseases Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Microscopic Polyangiitis Nervous System Diseases Respiratory Tract Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Vasculitis clinic

Toronto, Canada

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

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 outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Cardiovascular events

    Time frame: 12 Months

    Number of patients with cardiovascular events (IM, stroke) in each study arm between enrollments and month 12

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Christian Pagnoux

Other

Registry information

Official study 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")

Acronym: PRAVDA

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2020
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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