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

Primary Purpose

Bronchiectasis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Vitamin D

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Pulmonary Hospital , Tongji UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D group

Placebo group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Time to first acute exacerbation

Secondary Outcome Measures

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

Full Information

First Posted
July 22, 2015
Last Updated
July 23, 2015
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT02507843
Brief Title
Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis
Acronym
VIDB
Official Title
Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D group
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D3
Intervention Description
Oral Cholecalciferol(100000 IU) will be administered in Vitamin D group monthly for 6 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Migliol Placebo Oil
Intervention Description
Placebo will be administered in placebo group monthly for 6 months.
Primary Outcome Measure Information:
Title
Time to first acute exacerbation
Time Frame
one year
Secondary Outcome Measure Information:
Title
total number of exacerbations per group
Time Frame
one year
Title
percentage of patients with one or more exacerbations per year
Time Frame
one year
Title
severity of diseases
Description
FACED（FEV1% predicted, age, chronic colonization by Pseudomonas aeruginosa， radiological extent of the disease， and dyspnea） score
Time Frame
one year
Title
using of antibiotics
Description
types of antibiotics used during exacerbations
Time Frame
one year
Title
quality of life
Description
the Quality of Life-Bronchiectasis (QOL-B) questionnaire
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JinFu Xu
Phone
+86-13321922898
Email
13321922898@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JinFu Xu
Organizational Affiliation
Shanghai Pulmonary Hospital , Tongji University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Pulmonary Hospital , Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kei Fei
Phone
+86-021-65115006

12. IPD Sharing Statement

Citations:
PubMed Identifier
23076388
Citation
Chalmers JD, McHugh BJ, Docherty C, Govan JR, Hill AT. Vitamin-D deficiency is associated with chronic bacterial colonisation and disease severity in bronchiectasis. Thorax. 2013 Jan;68(1):39-47. doi: 10.1136/thoraxjnl-2012-202125. Epub 2012 Oct 16.
Results Reference
result
PubMed Identifier
23371406
Citation
Bartley J, Garrett J, Grant CC, Camargo CA Jr. Could vitamin d have a potential anti-inflammatory and anti-infective role in bronchiectasis? Curr Infect Dis Rep. 2013 Apr;15(2):148-57. doi: 10.1007/s11908-013-0321-9.
Results Reference
result
PubMed Identifier
24232697
Citation
Martinez-Garcia MA, de Gracia J, Vendrell Relat M, Giron RM, Maiz Carro L, de la Rosa Carrillo D, Olveira C. Multidimensional approach to non-cystic fibrosis bronchiectasis: the FACED score. Eur Respir J. 2014 May;43(5):1357-67. doi: 10.1183/09031936.00026313. Epub 2013 Nov 14.
Results Reference
result

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

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