Bronchiectasis
Conditions
Keywords
Vitamin D
Brief summary
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
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.
Interventions
DRUGCholecalciferol
Oral Cholecalciferol(100000 IU) will be administered in Vitamin D group monthly for 6 months.
DRUGPlacebo
Placebo will be administered in placebo group monthly for 6 months.
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first acute exacerbation | one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total number of exacerbations per group | one year | — |
| percentage of patients with one or more exacerbations per year | one year | — |
| severity of diseases | one year | FACED（FEV1% predicted, age, chronic colonization by Pseudomonas aeruginosa， radiological extent of the disease， and dyspnea） score |
| using of antibiotics | one year | types of antibiotics used during exacerbations |
| quality of life | one year | the Quality of Life-Bronchiectasis (QOL-B) questionnaire |
Countries
China
Contacts
Primary ContactJinFu Xu
Outcome results
None listed