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

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ClinicalTrials.gov Identifier: NCT02507843
Recruitment Status : Unknown
Verified July 2015 by Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China.
Recruitment status was:  Recruiting
First Posted : July 24, 2015
Last Update Posted : July 24, 2015
Sponsor:
Information provided by (Responsible Party):
Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

Tracking Information
First Submitted Date  ICMJE July 22, 2015
First Posted Date  ICMJE July 24, 2015
Last Update Posted Date July 24, 2015
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2015)
Time to first acute exacerbation [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2015)
  • total number of exacerbations per group [ Time Frame: one year ]
  • percentage of patients with one or more exacerbations per year [ Time Frame: one year ]
  • severity of diseases [ Time Frame: one year ]
    FACED(FEV1% predicted, age, chronic colonization by Pseudomonas aeruginosa, radiological extent of the disease, and dyspnea) score
  • using of antibiotics [ Time Frame: one year ]
    types of antibiotics used during exacerbations
  • quality of life [ Time Frame: one year ]
    the Quality of Life-Bronchiectasis (QOL-B) questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bronchiectasis
Intervention  ICMJE
  • Drug: Cholecalciferol
    Oral Cholecalciferol(100000 IU) will be administered in Vitamin D group monthly for 6 months.
    Other Name: Vitamin D3
  • Drug: Placebo
    Placebo will be administered in placebo group monthly for 6 months.
    Other Name: Migliol Placebo Oil
Study Arms  ICMJE
  • Active Comparator: Vitamin D group
    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.
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: Placebo group
    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.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 23, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02507843
Other Study ID Numbers  ICMJE 20150511
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China
Study Sponsor  ICMJE Shanghai Pulmonary Hospital, Shanghai, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: JinFu Xu Shanghai Pulmonary Hospital , Tongji University
PRS Account Shanghai Pulmonary Hospital, Shanghai, China
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP