Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp
Status: | Suspended |
---|---|
Conditions: | Other Indications, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Other |
Healthy: | No |
Age Range: | 19 - Any |
Updated: | 1/17/2018 |
Start Date: | October 2013 |
End Date: | December 2020 |
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.
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.
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.
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.
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)
We found this trial at
1
site
Emile St
Omaha, Nebraska 68198
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Lynn Mack, MD
Phone: 402-559-2146
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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