The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change in LDL Cholesterol Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years
- •Vitamin D 25-OH level < 20 ng/ml
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Oral Vitamin D3 (Dietary Supplement)
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.
干预措施: Ultraviolet Light (Radiation)
结局指标
主要结局
Change in LDL Cholesterol Level
时间窗: baseline and 6 months or last observation carried forward (minimum 2 months)
次要结局
- 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 HDL Cholesterol(baseline and 6 months or last observation carried forward (minimum 2 months))
- Change in Parathyroid Hormone (PTH)(baseline vs.6 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))
研究者
Manish Ponda
Assistant Professor of Clinical Investigation
Rockefeller University