Comparison of Absorption of Vitamin D in Cystic Fibrosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Dietary Supplement: Vitamin D Powder
* Dietary Supplement: Vitamin D Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 100,000 IU D-50 powder<br>Vitamin D oil vs powder. 100,000 IU powder form of vitamin D, assessment of D3 absorption. One Dose of vitamin D powder format administered. Absorption rate monitored over 72 hour period | Dietary Supplement: Vitamin D Powder<br>* Patients will be randomly assigned to a powder supplement of 100,000 IU vitamin D3. Randomization will be in blocks of 4 (meaning for every 4 subjects there will be 2 vitamin D and 2 placebo treated patients). Blood will be drawn by IV catheter at baseline, 2, 4, 8, 12, 24, 48, and 72 hours after vitamin D3 dosing<br>* Other names: D3-50 Cholecalciferol;|
| Active Comparator: 100,000 IU Maximum D3 in oil<br>Vitamin D oil vs powder. One Dose of 100,000 IU vitamin D oil format administered. Absorption rate monitored over 72 hour period | Dietary Supplement: Vitamin D Oil<br>* Patients will be randomly assigned to an oil based supplement of 100,000 IU vitamin D3. Randomization will be in blocks of 4 (meaning for every 4 subjects there will be 2 vitamin D and 2 placebo treated patients). Blood will be drawn by IV catheter at baseline, 2, 4, 8, 12, 24, 48, and 72 hours after vitamin D3 dosing<br>* Other names: Maximum D3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Absorption of vitamin D3 to blood | rates of absorption of D3 will be compared for either an oil based or powder form pill OVER 72 HOURS. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Vitamin D, absorption, vitamin Deficiency, fat soluble