Improving Vitamin D Status In Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

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.
    

Detailed description: 
      Hypothesis of this study: Our hypothesis is that other methods such as cholecalciferol
      replacement and/or low dose ultraviolet radiation to the skin may be more effective in
      raising serum 25-hydroxyvitamin D levels than conventional ergocalciferol therapy.

      Experimental strategy: We will conduct a prospective randomized trail to determine which
      recommended vitamin D therapy (tanning device, cholecalciferol or ergocalciferol) is
      effective in maintaining or improving vitamin D status during the winter months. We will
      recruit CF patients according to the following inclusion and exclusion criteria:

      Inclusion: 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: 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).

      Physicians at the Emory CF center will be informed about the study. The primary CF doctor of
      the subject will refer the individual to one of the study investigators for potential
      recruitment. The principal investigator or co-investigator will meet with the prospective
      subject to discuss the details of the study. If the subject agrees to participate, they will
      sign an informed consent form. The subject will provide a blood specimen at the screening
      visit to determine eligibility for the study including 25-hydroxyvitamin D. If the subject's
      25(OH)D level is ≤15 ng/ml (moderate vitamin D deficiency), the subject will be excluded from
      the study. We have decided to exclude those moderately to severely deficient patients for
      ethical reasons since these subjects may require more aggressive medical management in
      correction of vitamin D status.

      The subject will then be randomized to either ergocalciferol 50,000 IU once a a week for 12
      weeks, cholecalciferol 50,000 IU once a week for 12 weeks, or use of a portable tanning
      device 5 times a week for 12 weeks. The blood sample obtained for screening will be used to
      determine baseline 25(OH)D, parathyroid hormone (PTH). This assignment can not be blinded for
      obvious reasons. Subjects assigned to cholecalciferol or ergocalciferol will be instructed on
      how to take the pill three times a week. The subjects assigned to the portable tanning
      machine will be given instructions on how to operate the device.

      All subjects will complete a baseline three day food diary to determine daily calcium and
      vitamin D intake levels. Those subjects already taking calcium supplements will be instructed
      to take no more than 1500 mg of calcium a day. Those subjects already taking multivitamin
      supplements will be limited to no more than 800 IU of vitamin D daily. Subjects will be
      allowed to continue with their usual diet; however, they should limit the number of milk
      servings to no more than 3 servings a day. Subjects will also be instructed not to travel to
      sunny climates or visit tanning salons during the study. No restrictions will be made in
      regards to outdoor activities since minimal vitamin D is made during the winter months.
      Subjects will return to the CF center 12 weeks after the randomization for repeat blood tests
      for 25(OH)D and PTH. Every two weeks, our research coordinator will call the subject to
      discuss compliance with the assigned therapy. In particular, those subjects assigned to pills
      will be reminded to take the pills weekly. Those subjects assigned to UV light will be asked
      questions regarding presence of skin erythema, photosensitivity, evidence of tanning and any
      other potential side effects.
    

Intervention name(s): ergocalciferol (vitamin D2); Sperti Del Sol Lamp; Vitamin D3
Intervention type(s): Drug; Device; Drug
Intervention description(s): 50,000 IU weekly; 5 times a week for 12 weeks; 50,000 IU weekly
Other intervention name(s): D2; D3
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment