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PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis

NCT04280601 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2023-03-14

No results posted yet for this study

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).

Conditions

  • ANCA-associated Vasculitis
  • Granulomatosis With Polyangiitis
  • Microscopic Polyangiitis
  • Eosinophilic Granulomatosis With Polyangiitis

Interventions

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

Sponsors & Collaborators

  • Christian Pagnoux

    lead OTHER

Principal Investigators

  • Christian Pagnoux, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2023-03-01
Completion
2023-03-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04280601 on ClinicalTrials.gov