Brief Title
Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis
Official Title
Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled Trial
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Time to first acute exacerbation
Secondary Outcome
total number of exacerbations per group
Condition
Bronchiectasis
Intervention
Cholecalciferol
Study Arms / Comparison Groups
Vitamin D group
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
200
Start Date
January 2015
Completion Date
June 2017
Primary Completion Date
December 2016
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
JinFu Xu, +86-13321922898, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02507843
Organization ID
20150511
Responsible Party
Principal Investigator
Study Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study Sponsor
JinFu Xu, Principal Investigator, Shanghai Pulmonary Hospital , Tongji University
Verification Date
July 2015