Effect of Vitamin D and Statins on Plasma Lipid Profiles in Chinese Patients With Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- a change in serum total cholesterol level
研究概览
简要总结
The investigators planned to research the effect of vitamin D supplementation as an adjuvant therapy for patients with hypercholesterolemia.
详细描述
Vitamin D is primarily generated in the skin, in response to direct absorption of ultraviolet B radiation. Vitamin D can also be obtained through fortified foods and oral supplements. Lipid abnormalities are common in the general population, and are regarded as a modifiable risk factor for cardiovascular disease. Recently low vitamin D status has been shown to be associated with increased risk of developing hyperlipidemia. Statins are normally the first-line therapy for hypercholesterolemia. It is also reported that vitamin D can improve serum lipid levels. However, its effects on hypercholesterolemia patients remain unclear. The investigators planned to determine the efficacy of combination therapy with statins and vitamin D in a cohort of hypercholesterolemia patients. This study may shed light as to whether oral vitamin D supplementation can be an adjunct therapy in hypercholesterolemia patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria were for hypercholesterolemia patients with the treatment of statins.
排除标准
- •The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders. Patients were also excluded if they were taking vitamin D3 tablets or other lipid-regulating drugs.
研究组 & 干预措施
Vitamin D supplementation group
drug: vitamin D3 tablets (Vigantoletten; Merck Pharma, Germany); the frequency: 2000 IU vitamin D3 tablets were taken daily; duration: 6 months.
干预措施: vitamin D3 tablets (Drug)
Control group
drug: placebo tablets; the frequency: 2000 IU placebo tablets were taken daily; duration: 6 months.
干预措施: placebo tablets (Drug)
结局指标
主要结局
a change in serum total cholesterol level
时间窗: after 6 months of vitamin D supplementation
The primary end point was a change in serum total cholesterol level after 6 months of vitamin D supplementation.
次要结局
- a change in serum triglycerides level(after 6 months of vitamin D supplementation)
- differences in the incidences of treatment-emergent adverse events(after 6 months of vitamin D supplementation)
研究者
Shi Yang
Director of Geriatric Cardiology
Chinese PLA General Hospital
