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

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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