NCT04280601

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

February 18, 2020

Last Update Submit

March 13, 2023

Conditions

ANCA-associated VasculitisGranulomatosis With PolyangiitisMicroscopic PolyangiitisEosinophilic Granulomatosis With Polyangiitis

Keywords

Vitamin DANCAVasculitis

Outcome Measures

Primary Outcomes (1)

  • Disease activity and disease relapse (using BVAS)

    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)

    12 months

Secondary Outcomes (4)

  • Renal function (GFR)

    12 Months

  • Cardiovascular events

    12 Months

  • Interstitial lung disease diagnosis or progression (imaging and PFT)

    12 Months

  • Glucocorticoid use (and cumulative dose, mg)

    12 months

Study Arms (1)

Low vitamin level at baseline

OTHER

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

Interventions

vitamin DDIETARY_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

Low vitamin level at baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital, Vasculitis clinic

Toronto, Canada

Location

Related Links

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisGranulomatosis with PolyangiitisMicroscopic PolyangiitisChurg-Strauss SyndromeVasculitis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Systemic VasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGranulomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Christian Pagnoux, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, MPH, MSc

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 21, 2020

Study Start

August 1, 2020

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)