The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Oral Vitamin D3
* Radiation: Ultraviolet Light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Vitamin D 25-OH level < 20 ng/ml Exclusion Criteria: Serum calcium > 10.5 mg/dl Serum phosphorus > 5.5 mg/dl Serum parathyroid hormone (PTH) level < 12 pg/ml LDL cholesterol > 190 mg/dl History of recent acute infection (within 1 month) Glomerular filtration rate(GFR) < 60 mL/min Liver Function tests indicative of liver disease (aspartate aminotransferase (AST) or alanine transferase (ALT) > 3x ULN) Current use of Vitamin D > 400 IU/day Current use of any statins, fibrates, niacin, or ezetimibe Current use of any medications affecting sensitivity to UV light Pregnancy (self-reported) Intentional UV exposure (e.g. tanning bed use) in the last 2 weeks or planned use while participating in the study history of malignancy not in remission (> 6 months) History of malignant melanoma Participation in an investigational drug study within 30 days of the screening visit 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. History of any non-melanoma skin cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Vitamin D3<br>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D. | Dietary Supplement: Oral Vitamin D3<br>* 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed<br>|
| Active Comparator: Ultraviolet Light<br>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB. | Radiation: Ultraviolet Light<br>* 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL Cholesterol Level |  | baseline and 6 months or last observation carried forward (minimum 2 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Cholesterol | Change in Total Cholesterol | baseline and 6 months or last observation carried forward (minimum 2 months) | 
| Change in HDL Cholesterol |  | baseline and 6 months or last observation carried forward (minimum 2 months) | 
| Change in Triglycerides |  | baseline 6 months or last observation carried forward (minimum 2 months) | 
| Change in C Reactive Protein |  | baseline and 6 months | 
| Change in 25(OH)D |  | baseline vs. 6 months | 
| Change in Serum Calcium |  | baseline vs. 6 months | 
| Change in Parathyroid Hormone (PTH) |  | baseline vs.6 months |