Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis

Study Overview
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Brief Summary
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This study evaluates vitamin D as an adjunctive treatment in patients with non-Cystic Fibrosis bronchiectasis, which are combined with vitamin D deficiency. Half of participants will receive vitamin D supplementation, while the other half will receive placebo.

Detailed Description
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To define the therapeutic effect of Vitamin D in the treatment of non-Cystic Fibrosis bronchiectasis by means of a prospective randomized placebo-controlled double blind study with a follow-up of at least one year. To explore whether correction of Vitamin D deficiency by the oral supplementation of Vitamin D triggers the vitamin D receptors-mediated cathelicidin pathway and increases local or systemic concentrations of the natural antimicrobial polypeptide cathelicidin with enhanced eradication of bacteria.

Official Title
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Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled Trial

Conditions
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Bronchiectasis

Intervention / Treatment
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* Drug: Cholecalciferol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of non-Cystic fibrosis bronchiectasis by High Resolution CT Age 18 years or older Vitamin D deficiency [25(OH)D<20 ng/mL] Informed consent Exclusion Criteria: Current active allergic bronchopulmonary or tuberculosis Diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, Human Immunodeficiency Virus infection, liver failure, renal failure or malignancy Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone Taking dietary supplement or topical preparation containing vitamin D up to 2 months before first dose Treatment with any investigational medical product or device up to 4 months before first dose Breastfeeding, pregnant or planning a pregnancy Baseline corrected serum calcium > 2.65 mmol/L Baseline serum creatinine > 125 micromol/L

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D group<br>Cholecalciferol will be administered by monthly oral intake. During a prospective follow-up period of one year, the patients will get the normal care with some additional tests for the study. | Drug: Cholecalciferol<br>* Oral Cholecalciferol(100000 IU) will be administered in Vitamin D group monthly for 6 months.<br>* Other names: Vitamin D3;|
| Placebo Comparator: Placebo group<br>Placebo will be administered by monthly oral intake. During a prospective follow-up period of one year, the patients will get the normal care with some additional tests for the study. | Drug: Placebo<br>* Placebo will be administered in placebo group monthly for 6 months.<br>* Other names: Migliol Placebo Oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first acute exacerbation |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total number of exacerbations per group |  | one year | 
| percentage of patients with one or more exacerbations per year |  | one year | 
| severity of diseases | FACED（FEV1% predicted, age, chronic colonization by Pseudomonas aeruginosa， radiological extent of the disease， and dyspnea） score | one year | 
| using of antibiotics | types of antibiotics used during exacerbations | one year | 
| quality of life | the Quality of Life-Bronchiectasis (QOL-B) questionnaire | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D