The effect of treatment with high dose vitamin D on airway inflammation in non-atopic asthma.

The effect of treatment with high dose vitamin D on airway inflammation in non-atopic asthma. - Vitamin D in non-atopic asthma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32451

Enrollment

Registered

2010-01-28

Start date

2010-02-28

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma bronchitis

Interventions

One group receives a single dose of 400.000 IU orally administered vitamin D. The other group receives a placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Non-atopic asthma (negative alatop test and pulmonologist's diagnosis of asthma) neutrophilic and/or eosinophilic inflammation in induced sputum (>53% neutrophils and/or >3% eosinophils) >=18 yrs Documented reversibility in FEV1 of > 12% predicted OR airway hyperresponsiveness to inhaled methacholine

Exclusion criteria

Exclusion criteria: Allergy Pregnancy Contra-indications regarding vitamin D use: hypercalcaemia, malignancy, sarcoidosis, history of kidneystones. Patients with smoking history of >10 packyears and persistent airflow obstruction (post bronchodilator FEV1 100 nmol/l

Design outcomes

Primary

Measure	Time frame
Main study parameter: The change in percentage of neutrophils and/or eosinophils in induced sputum before and 8-10 weeks after vitamin D administration.	—

Secondary

Measure	Time frame
Secondary parameters: The changes in extent of sinus disease as measured on CT-sinus, levels of FEV1 and exhaled NO, quality of life (AQLQ), Asthma control (ACQ) and SNOT 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 potential predictors of response. The reproducibility of cell counts 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), and asthma control (ACQ) in non-atopic asthma will be determined in patients who received placebo.	—

Measure

Time frame

Secondary parameters: The changes in extent of sinus disease as measured on CT-sinus, levels of FEV1 and exhaled NO, quality of life (AQLQ), Asthma control (ACQ) and SNOT 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 potential predictors of response. The reproducibility of cell counts 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), and asthma control (ACQ) in non-atopic asthma will be determined in patients who received placebo.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)