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

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ClinicalTrials.gov Identifier: NCT04280601
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Christian Pagnoux, Mount Sinai Hospital, Canada

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021


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




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



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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

Information from the National Library of Medicine

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


Contacts
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Contact: Christian Pagnoux, MD 416 586 4800 ext 8549 cpagnoux@mtsinai.on.ca
Contact: Irena Doubelt, MD 416 586 4800 ext 8549 Irena.Doubelt@one-mail.on.ca

Locations
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Canada
Mount Sinai Hospital, Vasculitis clinic Recruiting
Toronto, Canada
Contact: Christian Pagnoux, MD       christian.pagnoux@sinaihealth.ca   
Sponsors and Collaborators
Christian Pagnoux
Investigators
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Principal Investigator: Christian Pagnoux, MD MOUNT SINAI HOSPITAL
Additional Information:
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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    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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
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
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents