Desktop Tanning Unit to Improve Vitamin D Status in Patients With Cystic Fibrosis and Short Bowel Syndrome: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 25-hydroxyvitamin D
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%.
排除标准
- •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).
研究组 & 干预措施
Vitamin D3
Vitamin D3=cholecalciferol 50,000 IU weekly
干预措施: Vitamin D3 (Drug)
vitamin D2
The intervention is an oral tablet of vitamin D2 (ergocaliferol 50,000 IU weekly) for 12 weeks.
干预措施: ergocalciferol (vitamin D2) (Drug)
Sunlamp
The intervention is the use of a Sunlamp (Sperti) to the skin 5 times a week for 12 weeks
干预措施: Sperti Del Sol Lamp (Device)
结局指标
主要结局
25-hydroxyvitamin D
时间窗: 12 weeks
This is a marker of vitamin D status
次要结局
- Parathyroid Hormone, Serum C-telopeptide, Osteocalcin(12 weeks)
研究者
Vin Tangpricha
Associate Professor
Atlanta VA Medical Center
