The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
- Conditions
- Vitamin D Deficiency
- Interventions
- Dietary Supplement: Oral Vitamin D3Radiation: Ultraviolet Light
- Registration Number
- NCT01688102
- Lead Sponsor
- Rockefeller University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- Age > 18 years
- Vitamin D 25-OH level < 20 ng/ml
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral Vitamin D3 Oral Vitamin D3 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. Ultraviolet Light Ultraviolet Light 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.
- Primary Outcome Measures
Name Time Method Change in LDL Cholesterol Level baseline and 6 months or last observation carried forward (minimum 2 months)
- Secondary Outcome Measures
Name Time Method Change in Parathyroid Hormone (PTH) baseline vs.6 months Change in Serum Calcium baseline vs. 6 months Change in Total Cholesterol baseline and 6 months or last observation carried forward (minimum 2 months) Change in Total Cholesterol
Change in HDL Cholesterol baseline and 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 Triglycerides baseline 6 months or last observation carried forward (minimum 2 months)
Trial Locations
- Locations (1)
The Rockefeller University
🇺🇸New York, New York, United States