Research

Cystic Fibrosis, Aspergillosis and the Effect of Vitamin D

Open-label Vitamin D Trial for Patients with Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis

Protocol Description

The purpose of this study is to see if giving vitamin D to patients with cystic fibrosis can reduce allergic reactions to the common fungus Aspergillus fumigatus found in throat cultures. This allergic reaction, also called ABPA, causes some patients to wheeze, cough or have difficulty breathing. Conventional treatment with “anti-fungal” medicine and high-dose steroids may be problematic for some, due to side effects on blood sugar levels and the bones. Recent studies have suggested that vitamin D is a critical factor in the development of cells that suppress allergic reactions.

Eligibility Criteria

Subject to certain exclusions, this study is open to patients of both genders, ages 12 and up, with a confirmed diagnosis of cystic fibrosis and past or present respiratory culture positive for Aspergillus fumigatus.
Males: Age 12 and older
Females: Age 12 and older

Requirements
Following the initial screening visit, participants will be given a supply of cholecalciferol (vitamin D3) to be taken orally every day for six months, in addition to the patient’s routine vitamin D supplement. At check up visits, examinations will include blood and urine sampling, and pulmonary function tests.
Visits: 4
Duration: 26 weeks

Status: Open for Enrollment

Source(s) of Support
National Heart, Lung and Blood Institute

Additional Information
Study Description at National Institutes of Health