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

• Status: Terminated
• Trial end date: 2017-03-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johannes Gutenberg University Mainz
• Collaborator: German Federal Ministry of Education and Research
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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