Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Hermes vitamin D | Other Identifier | Tangpricha |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100,000 IU D-50 powder | Active Comparator | 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 | Active Comparator | Vitamin D oil vs powder. One Dose of 100,000 IU vitamin D oil format administered. Absorption rate monitored over 72 hour period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D Powder | Dietary 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vin Tangpricha, MD PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22805498 | Result | 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. | |
| 22399505 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D001361 | Avitaminosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Vitamin D Oil | Dietary 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 |
|
|
| 12791627 | Result | 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. |
| 1550069 | Result | 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. |
| 8125859 | Result | 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. |
| 14717616 | Result | Hecker TM, Aris RM. Management of osteoporosis in adults with cystic fibrosis. Drugs. 2004;64(2):133-47. doi: 10.2165/00003495-200464020-00002. |
| 26903303 | Derived | 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. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |