N/A
N=11
Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp
Vitamin D Deficiency · Short Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01930539 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: 25 Hydroxy Vitamin D Levels — 26; 14; 19; 17 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultraviolet B lamp (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 25 Hydroxy Vitamin D Levels |
26; 14; 19; 17 | — |
| SECONDARY Serum Intact Parathyroid Hormone Level |
62; 70; 139; 82 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01930539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.