Clinical trial NCT01880346: Comparison of Absorption of Vitamin D in Cystic Fibrosis
Official title: Vehicles for the Absorption of Vitamin D in Cystic Fibrosis: Comparison of Powder vs Oil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Vitamin D
absorption
vitamin Deficiency
fat soluble
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Absorption of vitamin D3 to blood
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Vin Tangpricha, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grossmann RE, Zughaier SM, Liu S, Lyles RH, Tangpricha V. Impact of vitamin D supplementation on markers of inflammation in adults with cystic fibrosis hospitalized for a pulmonary exacerbation. Eur J Clin Nutr. 2012 Sep;66(9):1072-4. doi: 10.1038/ejcn.2012.82. Epub 2012 Jul 18.
citation: Tangpricha V, Kelly A, Stephenson A, Maguiness K, Enders J, Robinson KA, Marshall BC, Borowitz D; Cystic Fibrosis Foundation Vitamin D Evidence-Based Review Committee. An update on the screening, diagnosis, management, and treatment of vitamin D deficiency in individuals with cystic fibrosis: evidence-based recommendations from the Cystic Fibrosis Foundation. J Clin Endocrinol Metab. 2012 Apr;97(4):1082-93. doi: 10.1210/jc.2011-3050. Epub 2012 Mar 7.
citation: Tangpricha V, Koutkia P, Rieke SM, Chen TC, Perez AA, Holick MF. Fortification of orange juice with vitamin D: a novel approach for enhancing vitamin D nutritional health. Am J Clin Nutr. 2003 Jun;77(6):1478-83. doi: 10.1093/ajcn/77.6.1478.
citation: Johnson EJ, Krasinski SD, Howard LJ, Alger SA, Dutta SK, Russell RM. Evaluation of vitamin A absorption by using oil-soluble and water-miscible vitamin A preparations in normal adults and in patients with gastrointestinal disease. Am J Clin Nutr. 1992 Apr;55(4):857-64. doi: 10.1093/ajcn/55.4.857.
citation: Roum JH, Buhl R, McElvaney NG, Borok Z, Crystal RG. Systemic deficiency of glutathione in cystic fibrosis. J Appl Physiol (1985). 1993 Dec;75(6):2419-24. doi: 10.1152/jappl.1993.75.6.2419.
citation: Hecker TM, Aris RM. Management of osteoporosis in adults with cystic fibrosis. Drugs. 2004;64(2):133-47. doi: 10.2165/00003495-200464020-00002.
citation: Hermes WA, Alvarez JA, Lee MJ, Chesdachai S, Lodin D, Horst R, Tangpricha V. Prospective, Randomized, Double-Blind, Parallel-Group, Comparative Effectiveness Clinical Trial Comparing a Powder Vehicle Compound of Vitamin D With an Oil Vehicle Compound in Adults With Cystic Fibrosis. JPEN J Parenter Enteral Nutr. 2017 Aug;41(6):952-958. doi: 10.1177/0148607116629673. Epub 2016 Feb 22.