N/A
N=30
Improving Vitamin D Status In Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00450073 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: 25-hydroxyvitamin D — 21.2; 24.4; 28.2 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ergocalciferol (vitamin D2) (Drug); Sperti Del Sol Lamp (Device); Vitamin D3 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Atlanta VA Medical Center
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 25-hydroxyvitamin D |
21.2; 24.4; 28.2 | — |
| SECONDARY Parathyroid Hormone, Serum C-telopeptide, Osteocalcin |
— | — |
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.
Eligibility Criteria
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 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).
Data sourced from ClinicalTrials.gov (NCT00450073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.