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

• ClinicalTrials.gov Identifier: NCT04280601
• Recruitment Status: Completed
• First Posted: February 21, 2020
• Last Update Posted: March 14, 2023
• Sponsor: Christian Pagnoux
• Information provided by (Responsible Party): Christian Pagnoux, Mount Sinai Hospital, Canada

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).

Condition or disease	Intervention/treatment	Phase
ANCA-associated Vasculitis; Granulomatosis With Polyangiitis; Microscopic Polyangiitis; Eosinophilic Granulomatosis With Polyangiitis	Dietary Supplement: vitamin D	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 102 participants
• Allocation: N/A
• 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)
• Primary Purpose: Treatment
• 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
• Actual Primary Completion Date: March 1, 2023
• Actual Study Completion Date: March 1, 2023

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada

Mount Sinai Hospital, Vasculitis clinic

Toronto, Canada

Sponsors and Collaborators

Christian Pagnoux

Investigators

• Principal Investigator: Christian Pagnoux, MD; MOUNT SINAI HOSPITAL

More Information

Additional Information:

Website of the Canadian vasculitis research network, listing ongoing studies and their status in Canada 

• Responsible Party: Christian Pagnoux, MD, MPH, MSc, Mount Sinai Hospital, Canada
• ClinicalTrials.gov Identifier: NCT04280601
• Other Study ID Numbers: 19-0039-E
• First Posted: February 21, 2020
• Last Update Posted: March 14, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christian Pagnoux, Mount Sinai Hospital, Canada:

Vitamin D; ANCA; Vasculitis

Additional relevant MeSH terms:

Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Vasculitis; Systemic Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Churg-Strauss Syndrome; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Skin Diseases, Vascular; Skin Diseases; Autoimmune Diseases; Immune System Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Vitamin D; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents