Effects of Vitamin D Supplementation on Lung Function in an Acute Pulmonary Exacerbation of Cystic Fibrosis

Completed · Not applicable · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

Vitamin D insufficiency is common in patients with cystic fibrosis. The investigators study will examine a large dose of vitamin D given to patients who have cystic fibrosis and are admitted to the hospital for a pulmonary exacerbation to determine whether vitamin D can improve clinical outcomes and whether the dose given is correct. The investigators hypothesis is that vitamin D therapy will improve production of anti-microbial peptides and will increase bacterial killing of microorganisms.

Key facts

Study ID

NCT00788138

Run by

Emory University

People needed

30

Starts

2008-10-01

Expected to finish

2010-09-01

Last updated by the study team

2010-10-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligibility Criteria
• Study subjects must be patients diagnosed with cystic fibrosis and seen at the Emory University Cystic Fibrosis Center who are admitted to Emory University Hospital for an acute pulmonary exacerbation of cystic fibrosis as determined by their primary cystic fibrosis physician or emergency room physician.
• Study subjects must agree to participate in the study and provide written informed consent.
• Histology: Not applicable.
• Site: Emory University Hospital.
• Stage of Disease: Admission to Emory University Hospital for an acute pulmonary exacerbation of cystic fibrosis as determined by their primary CF physician based on symptoms and clinical evaluation.
• Age: Study subjects must be > 18 years old.
• Performance Status: Study subjects will be adult cystic fibrosis patients admitted to the hospital for an acute pulmonary exacerbation who are able to tolerate oral medication and to provide written informed consent.
• Informed Consent Requirement: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English. An additional consent form will be provided to subjects who agree to long term storage of their blood, sputum, saliva, and exhaled breath for future use by investigators of this study.

You may not qualify if…

• Age < 18 years old.
• Inability to tolerate oral medications in the first 48 hours of admission.
• Prior other diseases: Patients with prior disorders potentially affecting vitamin D levels and metabolism of calcium and phosphate will be excluded. We will exclude patient with any known disorders of the endocrine system affecting vitamin D metabolism including: Hyperparathyroidism, known history of nephrolithiasis, any documented malignances, and advanced renal disease.
• Infection: Not applicable.
• Hematologic values that preclude entry into the study including serum creatinine > 1.5 mg/dL, to assist with exclusion of patients with renal disease, baseline serum 25-hydroxyvitamin D levels >80 ng/mL, and baseline calcium level > 10.5 mg/dL.

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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