The Effect of Vitamin D Repletion on Small LDL Particle Number in Subjects at Elevated Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Small LDL particle concentration
研究概览
简要总结
Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to others, and available as a dietary supplement. It is also produced in the body when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Vitamin D is essential for promoting calcium absorption and maintaining adequate serum calcium and phosphate concentrations to enable normal mineralization of bone and bone growth. Without sufficient vitamin D, bones can become thin, brittle, or misshapen. Vitamin D sufficiency prevents rickets in children and osteomalacia in adults. Together with calcium, vitamin D also helps protect older adults from osteoporosis. Many people have low levels of Vitamin D. Replacing Vitamin D is thought to help lower the risk of heart disease. Vitamin D may be helpful, but it could also be harmful. The investigators are studying the effect of Vitamin D on the level of a harmful kind of cholesterol. Participants will have their cholesterol levels measured and then receive either Vitamin D or a placebo. After 2 months of treatment, the investigators will measure their cholesterol levels again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years and < 85 years
- •Vitamin D 25-OH level <20 ng/ml
- •One of the following risk factors:
- •Known coronary artery disease (CAD) or a CAD equivalent (e.g. diabetes, chronic kidney disease, etc)
- •BMI > 30 kg/m2
- •Random Glucose Level > 200mg/dl
- •Increased Waist Circumference (male: > 40in; Females: > 35in.)
- •Decreased HDL (Male: < 40mg/dl; Female: < 50mf/dl)
- •Framingham Risk Score > 10%
- •hsCRP > 2 mg/L
排除标准
- •Serum phosphorus level > 5.5 mg/dl
- •Estimated GFR <30 ml/min/1.73m2
- •Use of Vitamin D >400 IU/day within 1 month of most recent Vitamin D 25-OH determination
- •Use of calcitriol or other "activated" vitamin D
- •Change in statin, ezetimibe, niacin, fibrate dose within 1 month
- •Concurrent participation in an investigational drug study
- •Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
- •Serum calcium level >10.5 mg/dl
- •anti-epileptic medication
- •triglycerides > 400 mg/dL
- •BMI > 40 kg/m2
- •Evidence of cirrhosis as evidenced by AST > 3 x upper limit, ALT > 3 x upper limit, bilirubin > 1.5 mg/dL , albumin < 3.0 g/dL, PT > 14.5 sec
- •Pregnant or Lactating Females
结局指标
主要结局
Small LDL particle concentration
时间窗: Visit 5
次要结局
未报告次要终点