Clinical trial NCT02507843: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bronchiectasis
Keywords: Vitamin D
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to first acute exacerbation
timeFrame: one year
Secondary outcomes:
measure: total number of exacerbations per group
timeFrame: one year
measure: percentage of patients with one or more exacerbations per year
timeFrame: one year
measure: severity of diseases
timeFrame: one year
measure: using of antibiotics
timeFrame: one year
measure: quality of life
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital , Tongji University
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital , Tongji University
name: JinFu Xu
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.