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

Vitamin D Deficiency Clinical Trial

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

Status Completed

Clinical Trial 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, 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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Vitamin D Deficiency

• NCT number: NCT01930539
• Study type: Interventional
• Source: University of Nebraska
• Status: Completed
• Phase: N/A
• Start date: September 16, 2013
• Completion date: December 1, 2015