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Sponsored by: |
Emory University |
---|---|
Information provided by: | Atlanta VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00788138 |
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.
Condition | Intervention |
---|---|
Cystic Fibrosis |
Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 30 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Vitamin D3 250,000 PO Once
|
Dietary Supplement: Vitamin D3
250,000 IU of vitamin D3
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2: Placebo Comparator
Matching Placebo
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Dietary Supplement: Placebo
Matching Placebo
|
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 health and the prevention of osteoporosis. In addition to skeletal benefits of vitamin D, recent evidence has demonstrated that vitamin D plays an important role in the regulation of the immune system by increasing anti-microbial peptides in the lung and other barrier sites. Whether improving vitamin D status in CF patients would enhance the immune system has not yet been explored in a clinical study. This would have significant clinical impact in CF care since vitamin D status remains undertreated, especially in the setting of infection. The hypothesis of this proposal is that rapid correction of vitamin D insufficiency will result in improved innate immunity by increasing production of anti-microbial peptides resulting in more effective killing of bacteria. To address our hypothesis, the following two aims are proposed: 1) To evaluate the effect of rapid correction of vitamin D insufficiency as an adjunctive therapy on production of anti-microbial peptides in acute respiratory exacerbation in CF patients 2) To determine the effect of vitamin D treatment on bacterial killing in acute respiratory exacerbation in CF patients and to correlate with free LL-37 levels in sputum. The long term objective of this proposal and of our research group is to study the role of nutrition including vitamin D to improve the immune system in the setting of infection in CF.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligibility Criteria
Exclusion Criteria:
Contact: Vin Tangpricha, MD, PhD | 404-727-7254 | vin.tangpricha@emory.edu |
United States, Georgia | |
Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Vin Tangpricha, MD, PhD 404-727-7254 vin.tangpricha@emory.edu | |
Sub-Investigator: Lindy Wolfenden, MD | |
Sub-Investigator: Thomas R Ziegler, MD |
Responsible Party: | Emory University School of Medicine ( Vin Tangpricha ) |
Study ID Numbers: | Inpatient Vitamin D in CF |
Study First Received: | November 7, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00788138 |
Health Authority: | United States: Federal Government |
Cystic Fibrosis Vitamin D Anti-microbial peptides |
Cholecalciferol Vitamin D Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Ergocalciferols Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
Pathologic Processes Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |