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Vitamin

Low vitamin level at baseline for Microscopic Polyangiitis (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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Side effects data

From 2014 Phase 3 trial • 300 Patients • NCT01224678

Neck pain

Musculoskeletal and connective tissue disorder - Other, specify

Pain

Gastroesophageal reflux disease

Appendicitis perforated

Colitis

Vomiting

Pain in extremity

Diarrhea

Constipation

Nausea

Back pain

Headache

Pelvic pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Unintended pregnancy

Irregular menstruation

Hypertension

100%

80%

60%

40%

20%

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

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