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

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 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

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