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临床试验/NCT02009787
NCT02009787Unknown不适用

Effect of Vitamin D and Statins on Plasma Lipid Profiles in Chinese Patients With Hypercholesterolemia

Shi Yang1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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

发起方
Shi Yang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shi Yang

Director of Geriatric Cardiology

Chinese PLA General Hospital

研究点 (1)

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