NCT02424552

Brief Summary

The purpose of the EVITA trial is to compare the effects of vitamin D therapy with placebo on reducing the dose of inhaled or oral corticosteroids in patients with severe asthma and vitamin D insufficiency.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

9 active sites

Status
terminated

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

April 14, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 26, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2017

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

April 14, 2015

Last Update Submit

April 28, 2017

Conditions

Asthma

Keywords

severe asthmavitamin Dtreatment

Outcome Measures

Primary Outcomes (1)

  • relative dose reduction of ICS or OCS at week 24 as assessed by total ICS or OCS dose

    24 weeks

Secondary Outcomes (8)

  • Exacerbations (rate of and time to first and subsequent exacerbations) as assessed by numbers of exacerbations

    24 weeks and 30 weeks

  • Asthma Control as assessed by ACQ score

    at weeks 4, 8, 12, 14, 18, 20, 24, and 28

  • Asthma Quality of Life as assessed by the Mini-AQLQ score

    at weeks 12, 18, 24 and 28

  • Pulmonary function test results as assessed by FEV1, FVC, IC, RV, TLC, and airway resistance

    at weeks 4, 8, 12, 14, 18, 20, 24, and 28

  • Levels of vitamin D as assessed by serum concentrations

    at weeks 12, 18, 24 and 28

  • +3 more secondary outcomes

Study Arms (2)

Vitamin D3

EXPERIMENTAL

Initial single dose 100000 IU, beginning from the second day 4000 IU/day for 24 weeks

Drug: Vitamin D3

Placebo

PLACEBO COMPARATOR

Amount of Placebo capsules corresponding to initial single dose of Vitamin D3, beginning from the second day amount of capsules corresponding to daily dose of Vitamin D for 24 weeks

Drug: Placebo

Interventions

Vitamin D3DRUG

Initial single dose 100000 IU, beginning from the second day 4000 IU/day for 24 weeks.

Also known as: Cholecalciferol
Vitamin D3
PlaceboDRUG

Filling material: lactose monohydrate, cellulose, magnesium stearate

Placebo

Eligibility Criteria

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

You may qualify if:

  • Male or female patients, age ≥ 18 years
  • A pulmonary specialist documented diagnosis of severe asthma according to the Global Initiative for Asthma and the German Asthma Network (GAN, www.german-asthma-net.de)
  • Treatment with long-acting β2-agonists (LABA) and inhaled corticosteroids (ICS) at a dose of at least 1000 µg beclomethasone (or equivalent) per day, - chronic oral corticosteroid (OCS) use is allowed Stable asthma medication for ≥1 month prior to screening (≥4 months for omalizumab)
  • Asthma Control Questionnaire (ACQ-5) score ≥ 1.5
  • Vitamin D insufficiency as defined by a serum vitamin D concentration of \< 30 ng/ml but ≥ 10 ng/ml at screening

You may not qualify if:

  • Patients on vitamin D substitution
  • Current smokers or ex-smokers with a smoking history of more than 10 pack-years
  • Pregnant or nursing women or women who intend to become pregnant during the study
  • Known impaired renal function (GFR \< 30 ml/min) and history of physician-diagnosed nephrolithiasis
  • Use of other investigational drugs during the study or within 30 days of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pneumologische Gemeinschaftspraxis Dr. Rolke & Dr. Rückert

Aschaffenburg, D-63739, Germany

Location

Medizinische Klinik III für Pneumologie, allergologie, Schlaf- und Beatmungsmedizin, Berufsgenossenschaftliches Universitätsklinikum Bochum-Bergmannsheil GmbH

Bochum, D-44789, Germany

Location

IKF Pneumologie GmbH & Co.KG

Frankfurt, D-60596, Germany

Location

Pneumologisches Forschungsinstitut der LungenClinic Grosshansdorf

Großhansdorf, D-22927, Germany

Location

Studienzentrum KPPK GmbH

Koblenz, D-56068, Germany

Location

KLB - Gesundheitsforschung Lübeck GmbH

Lübeck, D-23552, Germany

Location

Pneumologie, III. Medizinische Klinik, Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, D-55131, Germany

Location

Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II/Pneumologie

Regensburg, D-93053, Germany

Location

Lungenpraxis Schleswig

Schleswig, D-24837, Germany

Location

Related Publications (3)

  • Korn S, Hubner M, Jung M, Blettner M, Buhl R. Severe and uncontrolled adult asthma is associated with vitamin D insufficiency and deficiency. Respir Res. 2013 Feb 22;14(1):25. doi: 10.1186/1465-9921-14-25.

    PMID: 23432854BACKGROUND

  • Martineau AR, MacLaughlin BD, Hooper RL, Barnes NC, Jolliffe DA, Greiller CL, Kilpin K, McLaughlin D, Fletcher G, Mein CA, Hoti M, Walton R, Grigg J, Timms PM, Rajakulasingam RK, Bhowmik A, Rowe M, Venton TR, Choudhury AB, Simcock DE, Sadique Z, Monteiro WR, Corrigan CJ, Hawrylowicz CM, Griffiths CJ. Double-blind randomised placebo-controlled trial of bolus-dose vitamin D3 supplementation in adults with asthma (ViDiAs). Thorax. 2015 May;70(5):451-7. doi: 10.1136/thoraxjnl-2014-206449. Epub 2015 Feb 27.

    PMID: 25724847BACKGROUND

  • Castro M, King TS, Kunselman SJ, Cabana MD, Denlinger L, Holguin F, Kazani SD, Moore WC, Moy J, Sorkness CA, Avila P, Bacharier LB, Bleecker E, Boushey HA, Chmiel J, Fitzpatrick AM, Gentile D, Hundal M, Israel E, Kraft M, Krishnan JA, LaForce C, Lazarus SC, Lemanske R, Lugogo N, Martin RJ, Mauger DT, Naureckas E, Peters SP, Phipatanakul W, Que LG, Sheshadri A, Smith L, Solway J, Sullivan-Vedder L, Sumino K, Wechsler ME, Wenzel S, White SR, Sutherland ER; National Heart, Lung, and Blood Institute's AsthmaNet. Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial. JAMA. 2014 May;311(20):2083-91. doi: 10.1001/jama.2014.5052.

    PMID: 24838406BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Stephanie Korn, MD

    Johannes Gutenberg University Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 23, 2015

Study Start

June 26, 2015

Primary Completion

February 9, 2017

Study Completion

March 9, 2017

Last Updated

May 1, 2017

Record last verified: 2017-04

Locations

DE(9)