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 |
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.
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.
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
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