Comparison of Absorption of Vitamin D in Cystic Fibrosis



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 59
Updated:4/21/2016
Start Date:October 2013
End Date:October 2015

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Vehicles for the Absorption of Vitamin D in Cystic Fibrosis: Comparison of Powder vs Oil

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.

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.

Inclusion Criteria:

- Adult CF patients (age >18 years

- Able to tolerate oral medication

- Expected to survive the duration of the study

Exclusion Criteria:

- 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
We found this trial at
1
site
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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from
Atlanta, GA
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