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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

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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: Cholecalciferol Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled Trial
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
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.
Drug: Cholecalciferol
Oral Cholecalciferol(100000 IU) will be administered in Vitamin D group monthly for 6 months.
Other Name: Vitamin D3

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.
Drug: Placebo
Placebo will be administered in placebo group monthly for 6 months.
Other Name: Migliol Placebo Oil




Primary Outcome Measures :
  1. Time to first acute exacerbation [ Time Frame: one year ]

Secondary Outcome Measures :
  1. total number of exacerbations per group [ Time Frame: one year ]
  2. percentage of patients with one or more exacerbations per year [ Time Frame: one year ]
  3. severity of diseases [ Time Frame: one year ]
    FACED(FEV1% predicted, age, chronic colonization by Pseudomonas aeruginosa, radiological extent of the disease, and dyspnea) score

  4. using of antibiotics [ Time Frame: one year ]
    types of antibiotics used during exacerbations

  5. quality of life [ Time Frame: one year ]
    the Quality of Life-Bronchiectasis (QOL-B) questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507843


Contacts
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Contact: JinFu Xu +86-13321922898 13321922898@163.com

Locations
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China, Shanghai
Shanghai Pulmonary Hospital , Tongji University Recruiting
Shanghai, Shanghai, China, 200000
Contact: Kei Fei    +86-021-65115006      
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Principal Investigator: JinFu Xu Shanghai Pulmonary Hospital , Tongji University

Publications of Results:
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Responsible Party: Jin-Fu Xu, MD, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT02507843     History of Changes
Other Study ID Numbers: 20150511
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015

Keywords provided by Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China:
Vitamin D

Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents