Comparison of Absorption of Vitamin D in Cystic Fibrosis

Emory University17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Vitamin D PowderDIETARY_SUPPLEMENT

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

Vitamin D OilDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

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

Locations (1)

Emory University Hospital

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: 72 hours

Data from ClinicalTrials.gov

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