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

Bronchiectasis Clinical Trial

— VIDB  

Official title:

Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02507843
• Other study ID #: 20150511
• Status: Recruiting
• Phase: Phase 4
• First received: July 22, 2015
• Last updated: July 23, 2015
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2015
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: JinFu Xu
• Phone: +86-13321922898
• Email: 13321922898[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• Cholecalciferol
Oral Cholecalciferol(100000 IU) will be administered in Vitamin D group monthly for 6 months.
• Placebo
Placebo will be administered in placebo group monthly for 6 months.

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital , Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View Citation

Martínez-García MÁ, de Gracia J, Vendrell Relat M, Girón RM, Máiz 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: 10.1183/09031936.0002 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first acute exacerbation		one year	No
Secondary	total number of exacerbations per group		one year	No
Secondary	percentage of patients with one or more exacerbations per year		one year	No
Secondary	severity of diseases	FACED(FEV1% predicted, age, chronic colonization by Pseudomonas aeruginosa, radiological extent of the disease, and dyspnea) score	one year	No
Secondary	using of antibiotics	types of antibiotics used during exacerbations	one year	No
Secondary	quality of life	the Quality of Life-Bronchiectasis (QOL-B) questionnaire	one year	No