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Vitamin
PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis (PRAVDA Trial)
N/A
Waitlist Available
Led By Christian Pagnoux, MD
Research Sponsored by Christian Pagnoux
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will provide vitamin D3 supplements to patients with AAV who have low vitamin D levels to see if it helps manage their disease and reduce flare-ups.
Eligible Conditions
- Microscopic Polyangiitis
- Churg-Strauss Syndrome
- Wegener's Granulomatosis
- Granulomatosis with polyangiitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease activity and disease relapse (using BVAS)
Secondary study objectives
Cardiovascular events
Glucocorticoid use (and cumulative dose, mg)
Diagnostic Imaging
+1 moreSide effects data
From 2014 Phase 3 trial • 300 Patients • NCT012246781%
Musculoskeletal and connective tissue disorder - Other, specify
1%
Neck pain
1%
Pain
1%
Gastroesophageal reflux disease
1%
Appendicitis perforated
1%
Colitis
1%
Vomiting
1%
Pain in extremity
1%
Diarrhea
1%
Constipation
1%
Nausea
1%
Back pain
1%
Headache
1%
Pelvic pain
1%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
1%
Unintended pregnancy
1%
Irregular menstruation
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Vitamin D
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Low vitamin level at baselineExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vitamin D
2013
Completed Phase 3
~2380
Find a Location
Who is running the clinical trial?
Christian PagnouxLead Sponsor
Christian Pagnoux, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL