Status:
COMPLETED
Effects of Vitamin D Supplementation on Lung Function in an Acute Pulmonary Exacerbation of Cystic Fibrosis
Lead Sponsor:
Emory University
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 ho...
Detailed Description
Vitamin D insufficiency is common in CF patients. Treatment of vitamin D insufficiency in CF patients requires large doses of vitamin D. Adequate vitamin D status in CF is important for skeletal healt...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00788138
Start Date
October 1 2008
End Date
September 1 2010
Last Update
October 11 2010
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322