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

Phase 4

• Conditions: Bronchiectasis
• Interventions: Drug: Placebo; Drug: Cholecalciferol

• Registration Number: NCT02507843
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-07
• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-23
• Last Update Submitted: 2015-07-23
• Study First Posted: 2015-07-24
• Last Update Posted: 2015-07-24
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	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.
Vitamin D group	Cholecalciferol	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.

Primary Outcome Measures

Name	Time	Method
Time to first acute exacerbation	one year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital , Tongji University; 🇨🇳 Shanghai, Shanghai, China