Comparison of Absorption of Vitamin D in Cystic Fibrosis

Phase 4

Completed

• Conditions: Cystic Fibrosis
• Interventions: Dietary Supplement: Vitamin D Powder; Dietary Supplement: Vitamin D Oil

• Registration Number: NCT01880346
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-19
• Study Start: 2013-10
• Primary Completion: 2015-03
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-19
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Adult CF patients (age >18 years
• Able to tolerate oral medication
• Expected to survive the duration of the study

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100,000 IU D-50 powder	Vitamin D Powder	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
100,000 IU Maximum D3 in oil	Vitamin D Oil	Vitamin D oil vs powder. One Dose of 100,000 IU vitamin D oil format administered. Absorption rate monitored over 72 hour period

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States