Comparison of Absorption of Vitamin D in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT01880346

Recruitment Status : Completed

First Posted : June 19, 2013

Last Update Posted : November 20, 2015

Sponsor:

Information provided by (Responsible Party):

Vin Tangpricha, MD, PH.D, Emory University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cystic Fibrosis	Dietary Supplement: Vitamin D Powder Dietary Supplement: Vitamin D Oil	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Vehicles for the Absorption of Vitamin D in Cystic Fibrosis: Comparison of Powder vs Oil
Study Start Date :	October 2013
Actual Primary Completion Date :	March 2015
Actual Study Completion Date :	October 2015

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 100,000 IU D-50 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	Dietary Supplement: Vitamin 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 Other Name: D3-50 Cholecalciferol
Active Comparator: 100,000 IU Maximum D3 in oil 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 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 Other Name: Maximum D3

Outcome Measures

Primary Outcome Measures :

Rate of Absorption of vitamin D3 to blood [ Time Frame: 72 hours ]
rates of absorption of D3 will be compared for either an oil based or powder form pill OVER 72 HOURS.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 59 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880346

Locations

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United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Investigators

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Principal Investigator:	Vin Tangpricha, MD PhD	Emory University

More Information

Publications of Results:

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.

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.

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.

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.

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.

Hecker TM, Aris RM. Management of osteoporosis in adults with cystic fibrosis. Drugs. 2004;64(2):133-47. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Vin Tangpricha, MD, PH.D, Associate Professor of Medicine, Emory University
ClinicalTrials.gov Identifier:	NCT01880346 History of Changes
Other Study ID Numbers:	IRB00066261 Hermes vitamin D ( Other Identifier: Tangpricha )
First Posted:	June 19, 2013 Key Record Dates
Last Update Posted:	November 20, 2015
Last Verified:	November 2015

Keywords provided by Vin Tangpricha, MD, PH.D, Emory University:


Cystic Fibrosis Vitamin D absorption vitamin Deficiency fat soluble

Additional relevant MeSH terms:

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Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Vitamin D	Ergocalciferols Cholecalciferol Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents

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