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van CCT (UK)

van CCT (UK)

Vitamin D in non-allergic asthma.

- candidate number7743
- NTR NumberNTR2205
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-feb-2010
- Secondary IDsNL 30108.099.09 CCMO
- Public TitleVitamin D in non-allergic asthma.
- Scientific TitleThe effect of treatment with high dose vitamin D on airway inflammation in non-atopic asthma.
- hypothesisWe hypothesize that supplementation of high doses of vitamin D in non-atopic asthmatic patients can reduce neutrophilic and/or eosinophilic airway inflammation.
- Healt Condition(s) or Problem(s) studiedNon-atopic asthma
- Inclusion criteria1. Outpatients with non-atopic asthma, determined by negative alatop;
2. Pulmonologist's diagnosis of asthma;
3. Age >=18;
4. Documented reversibility in FEV1 of >= 12%predicted OR airway hyperresponsiveness to inhaled methacholine;
5. Neutrophilic (>= 53%) or eosinophilic (>=3%) pattern of inflammation in induced sputum.
- Exclusion criteria1. Patients with smoking history of >10 packyears and persistent airflow obstruction (postbronchodilator FEV1<80%pred): Excluded if reversibility in FEV1 <12% predicted OR TLCO<80%pred;
2. Pregnancy;
3. Use of vitamin D analogues prior to this study;
4. Other pulmonary diseases;
5. History of kidney stones, sarcoidosis or malignancy;
6. Hypercalcaemia (corrected calcium > 2,60 mmol/l);
7. Vitamin D3 >100nmol.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2012
- Target number of participants62
- InterventionsPatients recieve a single dose of vitamin D (cholecalciferole) of 400.000IU or placebo orally.
- Primary outcomeThe change in percentage of neutrophils and/or eosinophils in induced sputum before and 8-10 weeks after vitamin D administration.
- Secondary outcome1. Extent of sinus disease as measured on CT-sinus;
2. Levels of FEV1 and exhaled NO;
3. Quality of life, Asthma control an SNOT-questionnaire.

Measurements will take place before and 8-10 weeks after vitamin D administration. Adverse events will be compared between the intervention group and placebo. Baseline characteristics will be used to identify potentials predictors of response.
- Timepoints1. Baseline;
2. 8-10 weeks after vitamin D administration.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Medical Center Leeuwarden
- Funding
(Source(s) of Monetary or Material Support)
Stichting Longgeneeskunde Fryslan
- PublicationsN/A
- Brief summaryNon-atopic asthma is often more severe than classic allergic asthma. It is associated with neutrophilic airway inflammation and decreased steroid responsiveness and therapies other than steroids are needed. Recently, accumulating epidemiological data are linking a low vitamin D nutritional status to asthma, respiratory infections and nasal polyps. In line with the novel insights on the immune function of vitamin D, it is tempting to speculate that vitamin D may down-regulate the neutrophilic immune response in the airways while boosting innate immune defence against different microorganisms. In addition, vitamin D may play a therapeutic role in steroid resistance. We hypothesize that treatment with high dose vitamin D will decrease neutrophilic and eosinophilic airway inflammation and improve asthma control. 62 patients with predominantly neutrophilic and/or eosinophilic airway inflammation are given one high dose of vitamin D (400.000 IU) or placebo. Primary outcome will be the change in percentage of neutrophils and/or eosinophils in induced sputum. Secondary outcomes will be the effect of supplementation of a single high dose of vitamin D on the percentage of eosinophils in induced sputum, extent of sinus disease as measured on CT-sinus, pulmonary function (FEV1), levels of exhaled nitric oxide (NO), quality of life (AQLQ), asthma control (ACQ) and adverse events in non-atopic asthmatic patients and to identify potential predictors of response.
- Main changes (audit trail)26-Nov-2010: An amendment has been made and has been approved on 28-Jun-2010 by the METC/RTPO Leeuwarden. Beside patients with neutrophilic airway inflammation, patients with eosinophilic airway inflammation may also be included. Number of participants changes from 52 to 62 - NM

05-Apr-2013: A new power analysis has been performed for the eosinophilic group. Turnes out that only 24 patients are necessary in this group. This has been approved by RTPO. Target Number of participants: 24 patients with neutrophilic and 24 patients with eosinophilic airway inflammation.
- RECORD8-feb-2010 - 5-apr-2013

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