The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
Status: | Completed |
---|---|
Conditions: | Other Indications, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Other |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 11/8/2017 |
Start Date: | September 2012 |
End Date: | July 2015 |
Participants in this study will be randomized to receive either oral vitamin D pills OR
ultraviolet light treatment. The investigators will compare how these two methods of raising
vitamin D levels will affect cholesterol levels.
ultraviolet light treatment. The investigators will compare how these two methods of raising
vitamin D levels will affect cholesterol levels.
Potential subjects will be screened for eligibility, including serum 25(OH)D levels <20ng/ml.
Eligible subjects will be randomly assigned to receive either: 1) oral vitamin D3, 50,000
units weekly for 8 weeks or 2) narrow-band UVB radiation, 2 treatments/wk for 8 weeks.
Duration of treatment will be based on skin type. After 8 weeks, 25(OH)D levels will be
measured monthly. For participants with levels <35 ng/ml, additional doses of oral vitamin D3
or UV radiation will be administered.
A subset of participants from both groups will participate in a skin biopsy cohort, where
skin biopsies are obtained before and after 8 weeks of treatment.
Eligible subjects will be randomly assigned to receive either: 1) oral vitamin D3, 50,000
units weekly for 8 weeks or 2) narrow-band UVB radiation, 2 treatments/wk for 8 weeks.
Duration of treatment will be based on skin type. After 8 weeks, 25(OH)D levels will be
measured monthly. For participants with levels <35 ng/ml, additional doses of oral vitamin D3
or UV radiation will be administered.
A subset of participants from both groups will participate in a skin biopsy cohort, where
skin biopsies are obtained before and after 8 weeks of treatment.
Inclusion Criteria:
1. Age > 18 years
2. Vitamin D 25-OH level < 20 ng/ml
Exclusion Criteria:
1. Serum calcium > 10.5 mg/dl
2. Serum phosphorus > 5.5 mg/dl
3. Serum parathyroid hormone (PTH) level < 12 pg/ml
4. LDL cholesterol > 190 mg/dl
5. History of recent acute infection (within 1 month)
6. Glomerular filtration rate(GFR) < 60 mL/min
7. Liver Function tests indicative of liver disease (aspartate aminotransferase (AST) or
alanine transferase (ALT) > 3x ULN)
8. Current use of Vitamin D > 400 IU/day
9. Current use of any statins, fibrates, niacin, or ezetimibe
10. Current use of any medications affecting sensitivity to UV light
11. Pregnancy (self-reported)
12. Intentional UV exposure (e.g. tanning bed use) in the last 2 weeks or planned use
while participating in the study
13. history of malignancy not in remission (> 6 months)
14. History of malignant melanoma
15. Participation in an investigational drug study within 30 days of the screening visit
16. Any medical, psychological or social condition that, in the opinion of the
Investigator, would jeopardize the health or well-being of the participant during any
study procedures or the integrity of the data.
17. History of any non-melanoma skin cancer
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