Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp
NCT ID: NCT01930539
Last Updated: 2023-10-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2013-09-16
2015-12-01
Brief Summary
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The investigators will use FDA approved portable Ultraviolet B lamp for the intervention group, 11 patients will be recruited from October 2013 to end of January 2014 and study period is 12 weeks for each patient. Study completion will be end of April 2014.
Study hypothesis: Ultraviolet B light with a portable ultraviolet device will increase Total 25 hydroxy vitamin D level in Intestinal Rehabilitation Clinic patients.
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Detailed Description
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Intestinal Rehabilitation clinic at University of Nebraska Medical Center includes patients with short bowel syndrome, multiple abdominal fistulae, and altered GI motility.
Hypovitaminosis D is associated with increased parathyroid hormone secretion,increased bone turnover, osteoporosis, histological osteomalacia and increased risk of hip and other fractures, and, in its most severe expression,clinical osteomalacia. These patients have been given high doses of both oral vitamin D2 and vitamin D3 supplementation without an improvement in vitamin D status due to poor intestinal absorption . Standardized treatment of vitamin D deficiency in most healthy individuals is achieved by giving vitamin D2 50,000 IU once a week for few weeks and then daily supplementation with lower doses. In the investigators Intestinal rehabilitation clinic, these patients are vitamin D insufficient or deficient while on large replacement doses of vitamin D2/D3 with some taking 200,000 IU daily.
It has been reported that irradiation with Ultraviolet B can be used safely and effectively to treat vitamin D deficiency among vitamin D deficient patients. Exposure of the body in a bathing suit to 1 Minimum Erythemal Dose (MED) of sunlight is equivalent to ingesting about 10,000 IU to 25,000 IU of vitamin D. Thus, exposure of 6% to 10% of the body surface to 1 MED is equivalent to ingesting about 600 to 2500 IU of vitamin D. Although ultraviolet irradiation can be achieved from exposure to sunlight, it is generally available only seasonally and difficult for persons who are too ill to spend much time outdoors. Ultraviolet-Fluorescent lamp (KBD, Inc, Crescent Springs, Kentucky,USA) was designed to use ultraviolet B emitting fluorescent bulbs that have lower heat emission and allows a larger area of skin exposure. The Lamp is equipped with a timer for improved safety. This device is FDA (Food and Drug Administration) approved.
Baseline labs include 25 hydroxy D, intact parathyroid hormone and complete metabolic profile. Patients will receive a 3 minute skin exposure to Ultraviolet B light and if they do not develop a sun burn, they will be randomized to Control or Ultraviolet B light group. Patients will continue their current dose of Vitamin D2/D3 for 12 weeks in both groups.Ultraviolet B light will be administered in 3 different areas on the same day for 5 minutes each, once a week at a distance of 14 inches wearing an UV eye shield. Areas of skin exposure will be based on rule of nine for body surface area which includes back, abdomen, thighs, and arms.
Patients will get blood draws at baseline and 12 weeks to monitor response to Ultraviolet B light. If Ultraviolet B light is able to increase total 25 hydroxy vitamin D level, it can potentially be used at home by these patients after receiving basic training and instructions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ultraviolet B lamp
Intervention arm: Patients in the Ultraviolet B lamp group will continue vitamin D2/D3 daily and will receive 3 treatment sessions of Ultraviolet B light once a week for 12 weeks. Patients will receive Ultraviolet B light from Ultraviolet B lamp at a distance of 14 inches for duration of 5 minutes each area while wearing an Ultraviolet eye shield. Areas of skin exposure will include 3 different areas amounting to 27% of body surface area. 9% body surface area will include front of abdomen, lower back, each arm, each leg is 18%, each thigh. Ultraviolet B light sessions will be supervised and conducted by study personnel or Center for Clinical and Translational Research staff. A food questionnaire will be reviewed at each visit to assess dietary intake of calcium. Skin exam will be conducted at the beginning and end of the session.
Ultraviolet B lamp
Ultraviolet-Fluorescent lamp (KBD, Inc, Crescent Springs, Kentucky, USA) was designed to use Ultraviolet B emitting fluorescent bulbs that have lower heat emission and allows a larger area of skin exposure. The Lamp is equipped with a timer for improved safety. This device is FDA (Food and Drug Administration) approved.
Control
Patients in control group will continue with their current dose of Vitamin D2/D3 for 12 weeks.Patients will remain on the same steady dose for the duration of the study.These patients will not receive Ultraviolet B light sessions.
No interventions assigned to this group
Interventions
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Ultraviolet B lamp
Ultraviolet-Fluorescent lamp (KBD, Inc, Crescent Springs, Kentucky, USA) was designed to use Ultraviolet B emitting fluorescent bulbs that have lower heat emission and allows a larger area of skin exposure. The Lamp is equipped with a timer for improved safety. This device is FDA (Food and Drug Administration) approved.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 19 years and above
* Patients on a stable dose of vitamin D2/D3 for last 3 months
Exclusion Criteria
* Symptomatic Hypocalcemia (described as tetany )
* History of Sarcoidosis or Granulomatous diseases
* Patients on Calcitriol
* Liver failure defined as bilirubin more than 3, International Normalized Ratio of more than 3, Hepatic Transaminases 3 times of upper limit of normal, Decompensated cirrhosis with signs or icterus, varices, portal hypertension, encephalopathy.
* History of transplant or undergoing transplant evaluation
* Planned or Elective surgery in 6 months
* Personal or Family history of skin cancer
* History of photosensitivity
* Active skin disease in the areas planned for Ultraviolet B exposure
* Medications that limit sunlight exposure (such as tetracyclines or fluoroquinolones)
* Patients already undergoing tanning sessions
* Patients who are planning pregnancy or are breastfeeding
* Subjects with fair skin type I (Always burns easily, never tans)
19 Years
ALL
No
Sponsors
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University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Lynn R Mack, MD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska Medical Center, Omaha
Locations
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University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
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References
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Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
Rosen CJ. Clinical practice. Vitamin D insufficiency. N Engl J Med. 2011 Jan 20;364(3):248-54. doi: 10.1056/NEJMcp1009570. No abstract available.
DiBaise JK, Young RJ, Vanderhoof JA. Intestinal rehabilitation and the short bowel syndrome: part 1. Am J Gastroenterol. 2004 Jul;99(7):1386-95. doi: 10.1111/j.1572-0241.2004.30345.x.
DiBaise JK, Young RJ, Vanderhoof JA. Intestinal rehabilitation and the short bowel syndrome: part 2. Am J Gastroenterol. 2004 Sep;99(9):1823-32. doi: 10.1111/j.1572-0241.2004.40836.x.
Armas LA, Dowell S, Akhter M, Duthuluru S, Huerter C, Hollis BW, Lund R, Heaney RP. Ultraviolet-B radiation increases serum 25-hydroxyvitamin D levels: the effect of UVB dose and skin color. J Am Acad Dermatol. 2007 Oct;57(4):588-93. doi: 10.1016/j.jaad.2007.03.004. Epub 2007 Jul 16.
Dabai NS, Pramyothin P, Holick MF. The effect of ultraviolet radiation from a novel portable fluorescent lamp on serum 25-hydroxyvitamin D3 levels in healthy adults with Fitzpatrick skin types II and III. Photodermatol Photoimmunol Photomed. 2012 Dec;28(6):307-11. doi: 10.1111/phpp.12000.
Chandra P, Wolfenden LL, Ziegler TR, Tian J, Luo M, Stecenko AA, Chen TC, Holick MF, Tangpricha V. Treatment of vitamin D deficiency with UV light in patients with malabsorption syndromes: a case series. Photodermatol Photoimmunol Photomed. 2007 Oct;23(5):179-85. doi: 10.1111/j.1600-0781.2007.00302.x.
Khazai NB, Judd SE, Jeng L, Wolfenden LL, Stecenko A, Ziegler TR, Tangpricha V. Treatment and prevention of vitamin D insufficiency in cystic fibrosis patients: comparative efficacy of ergocalciferol, cholecalciferol, and UV light. J Clin Endocrinol Metab. 2009 Jun;94(6):2037-43. doi: 10.1210/jc.2008-2012. Epub 2009 Mar 31.
Related Links
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Portable Ultraviolet B lamp
Other Identifiers
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0395-13-FB
Identifier Type: -
Identifier Source: org_study_id
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