Vehicles for the Absorption of Vitamin D in Cystic Fibrosis: Comparison of Powder vs Oil
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Rate of Absorption of vitamin D3 to blood
研究概览
简要总结
The investigators predict that a powder pill form of vitamin D will be more effectively absorbed than an oil form of vitamin D in people diagnosed with Cystic Fibrosis.
详细描述
The purpose of this study is to see how well two different forms of vitamin D work in Cystic Fibrosis (CF). Patients with Cystic Fibrosis have a hard time absorbing certain foods and often have low vitamin D levels. Studies show that vitamin D may help fight infections common in Cystic Fibrosis. The investigators would like to see if a powder pill form of vitamin D will work better than a pill mixed with oil. Each person will randomly receive either a powder pill or an oil based pill. Blood will be tested while during a 3-4 day hospital stay. The investigators plan to enroll no more than 24 patients with CF from Emory University Hospital for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult CF patients (age >18 years
- •Able to tolerate oral medication
- •Expected to survive the duration of the study
排除标准
- •Inability to obtain or declined informed consent from the subject and/or legally authorized representative
- •History of disorders associated with hypercalcemia
- •Current hypercalcemia (albumin-corrected serum calcium >10.8 mg/dL or ionized calcium >5.2 mg/dL)
- •Chronic kidney disease worse than stage III (<60 ml/min), 7) Forced Expiratory Volume (FEV1)% predicted <20%
- •Current significant hepatic dysfunction total bilirubin > 2.5 mg/dL with direct bilirubin > 1.0 mg/dL
- •Current use of cytotoxic or immunosuppressive drugs
- •History of AIDS or illicit drug abuse
- •too ill to participate in study based on investigator's or study team's opinion
- •current enrollment in another intervention trial
结局指标
主要结局
Rate of Absorption of vitamin D3 to blood
时间窗: 72 hours
rates of absorption of D3 will be compared for either an oil based or powder form pill OVER 72 HOURS.
次要结局
未报告次要终点
研究者
Vin Tangpricha, MD, PH.D
Associate Professor of Medicine
Emory University