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

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Unknown; Phase 4

Conditions: Bronchiectasis

Treatments: Drug: Cholecalciferol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02507843

20150511

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Vitamin D group

Active Comparator group

Description:

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.

Treatment:

Drug: Cholecalciferol

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo