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Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp

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ClinicalTrials.gov Identifier: NCT01930539
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Lynn Mack, MD, University of Nebraska

Brief Summary:

This is a randomized, controlled, unblinded pilot study for patients with vitamin D deficiency in Intestinal Rehabilitation clinic. These patients are not able to absorb oral vitamin D efficiently and thus have a high prevalence of vitamin D deficiency, leading to low bone density.

The investigators will use FDA approved portable Ultraviolet B lamp for the intervention group, 70 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 UV device will increase Total 25 hydroxy vitamin D level in Intestinal Rehabilitation Clinic patients.


Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Short Bowel Syndrome Device: Ultraviolet B lamp Not Applicable

Detailed Description:

Vitamin D plays an integral role in bone metabolism and is one of the principal hormonal regulators of calcium and phosphorus absorption in the body. In 2011, the Endocrine Society defined Vitamin D deficiency as a 25 hydroxy vitamin D below 20 ng/ml and vitamin D insufficiency as a 25 hydroxy vitamin D of 21 ng/ml to 29 ng/ml.Without vitamin D, only 10 to 15% of dietary calcium and about 60% of phosphorus is absorbed.

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 every 4 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp
Study Start Date : October 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: 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 Name: Sperti sunlamp "Del Sol"; Sperti, Crescent Springs, Kentucky

No Intervention: 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.



Primary Outcome Measures :
  1. Change in Serum levels of 25 hydroxy vitamin D level from baseline to 12 weeks [ Time Frame: 12 weeks ]

    Our hypothesis is that Ultraviolet B light with a portable Ultraviolet device will increase Total 25 hydroxy vitamin D level in Intestinal Rehabilitation Clinic patients.

    We will measure serum level of 25 hydroxy D at baseline and every 4 weeks until 12th week to monitor the response of Ultraviolet B exposure administered by the portable Ultraviolet B lamp.



Secondary Outcome Measures :
  1. Change in Serum Intact Parathyroid hormone level from baseline to 12 weeks [ Time Frame: 12 weeks ]
    Hypovitaminosis D is associated with increased Parathyroid hormone secretion (inversely related to 25 hydroxy D),increased bone turnover, osteoporosis, histological osteomalacia and increased risk of hip and other fractures, and, in its most severe expression,clinical osteomalacia.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 25-hydroxy vitamin D level between 15ng/ml to 30mg/ml
  • Age 19 years and above
  • Patients on a stable dose of vitamin D2/D3 for last 3 months

Exclusion Criteria:

  • Hypercalcemia (Serum Calcium (calculated) more than 1 mg/dl above the upper limit of normal i.e 11.3 mg/dl)
  • 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)

Information from the National Library of Medicine

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): NCT01930539


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Lynn Mack, MD University of Nebraska Medical Center, Omaha
Additional Information:
Publications:

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Responsible Party: Lynn Mack, MD, MD, University of Nebraska
ClinicalTrials.gov Identifier: NCT01930539    
Other Study ID Numbers: 395-13-FB
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Short Bowel Syndrome
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes