Cystic Fibrosis
Conditions
Keywords
Cystic Fibrosis, Vitamin D, absorption, vitamin Deficiency, fat soluble
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTVitamin D Powder
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
DIETARY_SUPPLEMENTVitamin D Oil
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
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Absorption of vitamin D3 to blood | 72 hours | rates of absorption of D3 will be compared for either an oil based or powder form pill OVER 72 HOURS. |
Countries
United States
Outcome results
None listed