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Improving Vitamin D Status In Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00450073
Recruitment Status : Completed
First Posted : March 21, 2007
Results First Posted : February 21, 2014
Last Update Posted : February 21, 2014
Emory University
Information provided by (Responsible Party):
Vin Tangpricha, Atlanta VA Medical Center

Brief Summary:
The purpose of this study is to establish an effective method to correct vitamin D deficiency in subjects with cystic fibrosis. The investigators will examine cholecalciferol, ergocalciferol and UV light.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: ergocalciferol (vitamin D2) Device: Sperti Del Sol Lamp Drug: Vitamin D3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Desktop Tanning Unit to Improve Vitamin D Status in Patients With Cystic Fibrosis and Short Bowel Syndrome: A Pilot Study
Study Start Date : November 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Active Comparator: Vitamin D3
Vitamin D3=cholecalciferol 50,000 IU weekly
Drug: Vitamin D3
50,000 IU weekly
Other Name: D3

Active Comparator: vitamin D2
The intervention is an oral tablet of vitamin D2 (ergocaliferol 50,000 IU weekly) for 12 weeks.
Drug: ergocalciferol (vitamin D2)
50,000 IU weekly
Other Name: D2

Active Comparator: Sunlamp
The intervention is the use of a Sunlamp (Sperti) to the skin 5 times a week for 12 weeks
Device: Sperti Del Sol Lamp
5 times a week for 12 weeks

Primary Outcome Measures :
  1. 25-hydroxyvitamin D [ Time Frame: 12 weeks ]
    This is a marker of vitamin D status

Secondary Outcome Measures :
  1. Parathyroid Hormone, Serum C-telopeptide, Osteocalcin [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects seen initially at the Emory CF center between the months of September and December
  • Age > 16, both males and females, confirmed cystic fibrosis by genetic testing or sweat testing, FEV1 > 40%.

Exclusion Criteria:

  • History of lung transplant or awaiting lung transplantation
  • Current hospitalization or greater than 6 hospitalizations/year
  • History of malignancy, renal disease (calculated GFR < 50% reduced from normal), liver disease (AST or AST > 3 times upper limit of normal), greater than 10 mg of prednisone or equivalent, hypercalcemia
  • History of easily burned skin after sunlight exposure, taking medications with may cause photosensitivity
  • History of skin cancer or multiple moles or family history of skin cancer
  • Moderate to severe vitamin D deficiency (25(OH)D ≤ 15 ng/ml).

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): NCT00450073

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United States, Georgia
Emory CF Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Atlanta VA Medical Center
Emory University
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Principal Investigator: Vin Tangpricha, M.D. Ph.D. Emory University
Publications of Results:
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Responsible Party: Vin Tangpricha, Associate Professor, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00450073    
Other Study ID Numbers: Cystic Fibrosis Vitamin D
First Posted: March 21, 2007    Key Record Dates
Results First Posted: February 21, 2014
Last Update Posted: February 21, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Vitamin D
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents