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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02507843
• Date of registration: 22/07/2015
• Prospective Registration: No
• Primary sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Public title: Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis VIDB
• Scientific title: Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled Trial
• Date of first enrolment: January 2015
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02507843
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Kei Fei

• Name: JinFu Xu

• Name: JinFu Xu
• Affiliation: Shanghai Pulmonary Hospital , Tongji University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bronchiectasis

Intervention(s)

Drug: Placebo

Drug: Cholecalciferol

Primary Outcome(s)

Time to first acute exacerbation [Time Frame: one year]

Secondary Outcome(s)

severity of diseases [Time Frame: one year]

quality of life [Time Frame: one year]

percentage of patients with one or more exacerbations per year [Time Frame: one year]

total number of exacerbations per group [Time Frame: one year]

using of antibiotics [Time Frame: one year]

Secondary ID(s)

20150511

Source(s) of Monetary Support

Please refer to primary and secondary sponsors