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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788138
First Posted: November 10, 2008
Last Update Posted: October 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Atlanta VA Medical Center
  Purpose
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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Atlanta VA Medical Center:

Primary Outcome Measures:
  • Vitamin D status measured by serum 25-hydroxyvitamin D [ Time Frame: 3 months ]
  • Antimicrobial peptide levels of LL-37, an endogenous anti-microbial peptide in humans [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Markers of pulmonary function measured by FEV1 % predicted [ Time Frame: 3 months ]
  • Length of hospitalization measured in days [ Time Frame: 3 months ]
  • Number of days on antibiotic therapy [ Time Frame: 3 months ]

Estimated Enrollment: 30
Study Start Date: October 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Vitamin D3 250,000 PO Once
Dietary Supplement: Vitamin D3
250,000 IU of vitamin D3
Other Name: Cholecalciferol
Placebo Comparator: 2
Matching Placebo
Dietary Supplement: Placebo
Matching Placebo

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 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.
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788138


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
  More Information

Responsible Party: Vin Tangpricha, Emory University School of Medicine
ClinicalTrials.gov Identifier: NCT00788138     History of Changes
Other Study ID Numbers: Inpatient Vitamin D in CF
First Submitted: November 7, 2008
First Posted: November 10, 2008
Last Update Posted: October 11, 2010
Last Verified: October 2010

Keywords provided by Atlanta VA Medical Center:
Cystic Fibrosis
Vitamin D
Anti-microbial peptides

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents


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