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Vitamin

Low vitamin level at baseline for ANCA 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

PRAVDA Trial Summary

This trial will test whether vitamin D3 supplements can improve symptoms or lower the risk of flares in people with antineutrophil cytoplasmic antibody-associated vasculitis.

Eligible Conditions

ANCA Vasculitis
Churg-Strauss Syndrome
Wegener's Granulomatosis
Microscopic Polyangiitis

PRAVDA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease activity and disease relapse (using BVAS)

Secondary outcome measures

Cardiovascular events

Glucocorticoid use (and cumulative dose, mg)

Diagnostic Imaging

+1 more

Side effects data

From 2014 Phase 3 trial • 300 Patients • NCT01224678

Musculoskeletal and connective tissue disorder - Other, specify

Neck pain

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

PRAVDA 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Christian PagnouxLead Sponsor

Christian Pagnoux, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings left for participants in this research initiative?

"Data found on clinicaltrials.gov reveals that this trial has ceased recruiting patients, with its initial posting dating to August 1st 2020 and the most recent update posted on February 15th 2022. However, there are still 44 other trials actively seeking participants as of now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis

Christian Pagnoux 2020. "PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04280601.