Ultraviolet Light And Vitamin D In Subjects With Fat Malabsorption Or After Gastric Bypass Surgery
Patients with fat malabsorption due to Crohn's disease, ulcerative colitis, or other causes including cystic fibrosis, among others, or who have undergone gastric bypass have increased incidence of vitamin D deficiency relative to the general population. Given that vitamin D is fat soluble and absorbed in the proximal small intestine, it has been documented that vitamin D deficiency in people with a fat malabsorption syndrome is due to decreased absorption of vitamin D.
The amount of vitamin D produced from winter sunlight (in Boston, MA) and dietary sources will negligibly raise blood vitamin D levels in these patients, and oral vitamin D supplementation may have limited efficacy due to malabsorption. A variety of UV light sources have been developed and sold as in-home tanning devices and to produce vitamin D in reptiles. The efficacy of correcting vitamin D deficiency by the skin exposure to an artificial source of UVB radiation in patients with fat malabsorption syndromes (Crohn's disease, ulcerative colitis, or cystic fibrosis) or after gastric bypass surgery has not been studied. The investigators have conducted a pilot study in healthy adults that demonstrated that exposure to the lamp raised the blood level of 25-hydroxyvitamin D with no side effects. The main purpose of this study is to evaluate the effect of the FDA approved artificial source of ultraviolet (UVB) radiation (Sperti® lamp) in improving vitamin D status in patients with fat malabsorption syndromes and patients who have undergone roux-en-Y gastric bypass surgery.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ultraviolet Light and Vitamin D in Subjects With Fat Malabsorption or After Gastric Bypass Surgery|
- Enhance Vitamin D Status [ Time Frame: Baseline, Months 1, 2, 3 ] [ Designated as safety issue: No ]Increase circulating 25(OH)D levels
- Erythema [ Time Frame: Baseline, Months 1, 2, 3 ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Group 2
Patients who have had gastric bypass surgery will use a UV Lamp at home 3x per week.
Device: UV lamp
Exposure to UV lamp 3 times a week for 12 weeks
Active Comparator: Group 1
Patients with fat malabsorption syndromes will use a UV lamp at home 3x per week.
Device: UV lamp
UV light exposure 3 times per week for 12 weeks
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01910792
|Contact: Michael F Holick, PhD, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Boston Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Jaimee M Bogusz, BS 617-638-8860 email@example.com|
|Principal Investigator: Michael F Holick, PhD, MD|
|Principal Investigator:||Michael F Holick, PhD, MD||BUMC|