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Effect of Vitamin D as add-on Therapy for Vitamin D Insufficient Patients With Severe Asthma (EVITA)

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ClinicalTrials.gov Identifier: NCT02424552
Recruitment Status : Terminated (recruitment problems)
First Posted : April 23, 2015
Last Update Posted : May 1, 2017
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
PD Dr. Stephanie Korn, Johannes Gutenberg University Mainz

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Vitamin D3 Drug: Placebo Phase 4

Detailed Description:

Patients with severe asthma represent the greatest unmet medical need among the asthmatic population, in particular due to their high risk of severe exacerbations. A substantial proportion of these patients does not achieve asthma control despite even high-dose ICS and LABA treatment, necessitating add-on therapy. For these patients oral corticosteroids (OCS) are a preferred treatment modality, which will inevitably lead to severe side effects. A high Proportion of patients with severe Asthma are Vitamin D insufficient (< 30 ng/ml). It is therefore tempting to speculate that vitamin D substitution in vitamin D insufficient patients who continue to experience suboptimal asthma control on ICS and LABA or ICS/LABA plus OCS treatment may boost corticosteroid responsiveness, thereby potentially reducing corticosteroid dose requirements and improving key parameters of asthma control.

The present study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of treatment with vitamin D at a dose of 4000 IU/day administered daily following a single loading dose of 100 000 IU upon study entry over a period of 24 weeks in patients with severe asthma and vitamin D insufficiency. During the study, all patients will remain on their existing maintenance asthma therapy throughout the study, in addition to the study treatment, while reducing inhaled or oral steroids according to study protocol. The study consists of a 2-week run-in period, a 24 week double-blind treatment period including a 12 week steroid stable phase and two steroid reduction phases, followed by a follow-up visit 4 weeks after last study medication intake. The active treatment arm in this study will be standard of care plus vitamin D (loading dose of 100 000 IU upon study entry, to be followed by 4000 IU/day for the rest of the study period) while the comparator arm will be standard of care plus placebo.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EVITA Trial: Effect of VItamin D as add-on Therapy for Vitamin D Insufficient Patients With Severe Asthma: a Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : June 26, 2015
Actual Primary Completion Date : February 9, 2017
Actual Study Completion Date : March 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D3
Initial single dose 100000 IU, beginning from the second day 4000 IU/day for 24 weeks
Drug: Vitamin D3
Initial single dose 100000 IU, beginning from the second day 4000 IU/day for 24 weeks.
Other Name: Cholecalciferol

Placebo Comparator: Placebo
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
Filling material: lactose monohydrate, cellulose, magnesium stearate




Primary Outcome Measures :
  1. relative dose reduction of ICS or OCS at week 24 as assessed by total ICS or OCS dose [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Exacerbations (rate of and time to first and subsequent exacerbations) as assessed by numbers of exacerbations [ Time Frame: 24 weeks and 30 weeks ]
  2. Asthma Control as assessed by ACQ score [ Time Frame: at weeks 4, 8, 12, 14, 18, 20, 24, and 28 ]
  3. Asthma Quality of Life as assessed by the Mini-AQLQ score [ Time Frame: at weeks 12, 18, 24 and 28 ]
  4. Pulmonary function test results as assessed by FEV1, FVC, IC, RV, TLC, and airway resistance [ Time Frame: at weeks 4, 8, 12, 14, 18, 20, 24, and 28 ]
  5. Levels of vitamin D as assessed by serum concentrations [ Time Frame: at weeks 12, 18, 24 and 28 ]
  6. Proportion of patients that achieved vitamin D sufficiency [ Time Frame: at week 24 ]
  7. Assessment of safety and tolerability as assessed by number of adverse events [ Time Frame: up to 30 weeks ]
  8. Dyspnea as assessed by Baseline and Transition Dyspnea Indexes [ Time Frame: at weeks 12, 18, 24 and 28 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424552


Locations
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Germany
Pneumologische Gemeinschaftspraxis Dr. Rolke & Dr. Rückert
Aschaffenburg, Germany, D-63739
Medizinische Klinik III für Pneumologie, allergologie, Schlaf- und Beatmungsmedizin, Berufsgenossenschaftliches Universitätsklinikum Bochum-Bergmannsheil GmbH
Bochum, Germany, D-44789
IKF Pneumologie GmbH & Co.KG
Frankfurt, Germany, D-60596
Pneumologisches Forschungsinstitut der LungenClinic Grosshansdorf
Grosshansdorf, Germany, D-22927
Studienzentrum KPPK GmbH
Koblenz, Germany, D-56068
KLB - Gesundheitsforschung Lübeck GmbH
Lübeck, Germany, D-23552
Pneumologie, III. Medizinische Klinik, Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, D-55131
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II/Pneumologie
Regensburg, Germany, D-93053
Lungenpraxis Schleswig
Schleswig, Germany, D-24837
Sponsors and Collaborators
Johannes Gutenberg University Mainz
German Federal Ministry of Education and Research
Investigators
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Principal Investigator: Stephanie Korn, MD Johannes Gutenberg University Mainz

Publications:
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Responsible Party: PD Dr. Stephanie Korn, Principal Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT02424552     History of Changes
Other Study ID Numbers: 2014-003
2014-002363-15 ( EudraCT Number )
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by PD Dr. Stephanie Korn, Johannes Gutenberg University Mainz:
severe asthma
vitamin D
treatment

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents